Crohn Disease, Rectal Fistula
Conditions
Keywords
Drug Therapy
Brief summary
The main aim of the study is to assess the quality of life of people with Crohn's disease after treatment for complex perianal fistulas (CPF) in a standard clinic setting. Study doctors will review the participants' medical records in the last 3 years. Participants will also be asked to visit the clinic once to complete 1 questionnaire on their quality of life.
Detailed description
This is a national, observational, cross-sectional study. The study will assess the general QoL among CD participants with CPFs in the Portuguese routine clinical practice. This study will enroll approximately 80 participants. All participants will be enrolled in one observational cohort. The data will be collected retrospectively, from the medical records, on healthcare resource utilization and on the pharmacological and surgical treatments used for the management of CPFs in the three years prior to the inclusion visit. This multi-center trial will be conducted in Portugal. The overall duration of this study is approximately 8 months.
Interventions
None listed
Sponsors
Takeda
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Diagnosed with CD. 2. Presence of CPF(s), defined as \>=1 of the following criteria: * High intersphincteric, high transsphincteric, extrasphincteric, or suprasphincteric location; * \>=2 external openings; * Associated collections. 3. Attending routine gastroenterology appointments at the participating hospitals.
Exclusion criteria
1. Diagnosed with ulcerative colitis or indeterminate inflammatory bowel disease (IBD). 2. With non-complex fistulas or with fistulas types other than perianal (example, rectovaginal).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Meta-Scores of the 12-Item Short Form Health Survey (SF-12) Questionnaire's Physical Component Score [PCS-12] | At inclusion visit (Day 1) | SF-12 is 12-item self-report that assesses physical and mental health related general quality of life (QoL) whose results are expressed in terms of two meta-scores: the physical component summary (PCS) and the mental component summary (MCS), of which the PCS component is presented in this outcome measure. The PCS score has a range of 0 to 100. Higher scores indicate better physical functioning. |
| Meta-Scores of the SF-12 Questionnaire's Mental Component Score [MCS-12]) | At inclusion visit (Day 1) | SF-12 is 12-item self-report that assesses physical and mental health related general quality of life (QoL) whose results are expressed in terms of two meta-scores: the PCS and the MCS, of which the MCS component is presented in this outcome measure. The MCS score has a range of 0 to 100. Higher scores indicate better mental functioning. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sexual Quality of Life-Female (SQOL-F) Questionnaire Score for Female Participants | At inclusion visit (Day 1) | SQOL-F assessed the relationship between female sexual dysfunction and quality of life. It consists of 18 items, rated using a six-point scale (completely agree to completely disagree). The total score can range from 18 to 108 points. Higher scores indicate better female sexual quality of life. |
| Fecal Incontinence as Assessed by Wexner Score | At inclusion visit (Day 1) | Fecal incontinence is measured by Wexner score. It consists of five questions to assess the degree of incontinence (solid, liquid, gas, wears pad, lifestyle alteration). The frequency of each type of incontinence is rated on a scale ranging from 0 (never) to 4 (always or to once a day) so that the sum of the frequencies add up to a total score that ranges from 0 to 20. Higher scores indicate worse fecal incontinence. |
| Work Productivity and Activity Impairment (WPAI) as Assessed by WPAI Questionnaire Score | At inclusion visit (Day 1) | WPAI score was used to describe the indirect healthcare resources. It is self-administered 6-item questionnaire (scale of 0-10) which assesses the effect of disease on work productivity in the past 7 days obtained for absenteeism (work time missed), presenteeism (impairment at work / reduced on-the-job effectiveness), work productivity loss (overall work impairment / absenteeism plus presenteeism) and activity impairment / disability. Scores are presented as percentages (multiplying the scores by 100), Domain scores are expressed as a percentage, with a range of scores form 0-100%, with 0% representing no impact on productivity and 100% representing complete impact on productivity. Higher scores indicate greater impairment. |
| Number of Participants Characterized Based on Healthcare Resource Utilization (HCRU) Within Previous 3 Years | Up to 3 years prior to the inclusion visit at Day 1 | Number of participants characterized based on HCRU associated with complex perianal fistulas (CPFs) management within the three years prior to the inclusion visit were collected. HCRU includes gastroenterology and other medical specialty appointments for the management of CPF; emergency room visits due to CPF; hospitalizations (greater than or equal to \[\>=\] 24 hours) due to CPF, and intensive care unit (ICU) admission. Only categories with at least one participant with event are reported. |
| Number of Participants Categorized Based on Sociodemographic and Anthropometric Characteristics | At inclusion visit (Day 1) | Sociodemographic and anthropometric variables included age (in years), sex (male or female), and body mass index (BMI). |
| Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Score | At inclusion visit (Day 1) | The SIBDQ is an instrument used to assess QoL and is a disease-specific health-related quality of life questionnaire, that consists of 10 questions, each question is scored on a scale from 1 (poor quality of life) to 7 (good quality of life). The total score is reported and ranges from 10 to 70 with a higher score indicating a better health-related QoL. |
| Number of Participants Characterized Based on Pharmacological Treatments and Surgeries for CPF | Up to 3 years prior to the inclusion visit at Day 1 | For each pharmacological treatment (antibiotics, monoclonal antibodies, immunosuppressants, and others), participants were divided into three categories (current users, past users, and non-users) considering the three years prior to the inclusion visit. Surgical treatment in the last three years for the management of CPF was also recorded. A participant may be included in more than one category. |
| Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables | At inclusion visit (Day 1) | The following qualitative variables were considered for the bivariate analysis: sex, smoking status, employment status, extraintestinal manifestations of Crohn's disease, Montreal classification for CD disease (age at onset, disease location, and disease behavior), fistula type and position, CD disease activity, treatment-naïve, surgery-naïve, type of surgery, and presence of seton, perianal abscess and anorectal stricture. PCS-12 scores were transformed to a 0 to 100, with higher scores indicating better quality of life. |
| Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables | At inclusion visit (Day 1) | The following qualitative variables were considered for the bivariate analysis: sex, smoking status, employment status, extraintestinal manifestations of Crohn's disease, Montreal classification for CD disease (age at onset, disease location, and disease behavior), fistula type and position, CD disease activity, treatment-naïve, surgery-naïve, type of surgery, and presence of seton, perianal abscess and anorectal stricture. MCS-12 scores were transformed to a 0 to 100, with higher scores indicating better quality of life. |
| Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as Correlation Coefficient Stratified Based on Quantitative Variables | At inclusion visit (Day 1) | The following quantitative variables were considered for bivariate analysis: age, BMI, time between CD diagnosis date and date of study visit, total number of CPFs per participant, time between first CPF diagnosis date and date of study visit, Perianal Disease Activity Index (PDAI) score, number of internal and external fistula openings, time since seton placement, SIBDQ score, SQoL-M score (for male participants) and SQoL-F score (for female participants), and Wexner score. Data was collected and reported as number for all the quantitative variables as the associations (correlation coefficient) between general QoL and the quantitative variables was calculated using Spearman Correlation Coefficients. |
| Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as Correlation Coefficient Stratified Based on Quantitative Variables | At inclusion visit (Day 1) | The following quantitative variables were considered for bivariate analysis: age, BMI, time between CD diagnosis date and date of study visit, total number of CPFs per participant, time between first CPF diagnosis date and date of study visit, PDAI score, number of internal and external fistula openings, time since seton placement, SIBDQ score, SQoL-M score (for male participants) and SQoL-F score (for female participants), and Wexner score. Data was collected and reported as number for all the quantitative variables as the associations (correlation coefficient) between general QoL and the quantitative variables was calculated using Spearman Correlation Coefficients. |
| Number of Participants With Moderate to Severe Crohn's Disease (CD) Stratified by Clinical Characteristics | At inclusion visit (Day 1) | The Montreal classification index for CD is used to classify the extent of the disease activity. It consists of two parameters: location and behavior of the disease activity. There are four different disease locations presented: Location 1 (L1) is ileum, Location 2 (L2) is colonic disease, Location 3 (L3) is ileocolon and Location 4 (L4) is isolated upper gastrointestinal (GI) tract disease. The first three categories (L1-L3) is combined with L4 where disease sites coexisted. There are 4 different categories for the behavior of the disease activity: Behavior 1 (B1) is non stenosing or non penetrating; Behavior 2 (B2) was stenosing; Behavior 3 (B3) is penetrating and p as perianal disease (p). The first 3 categories (B1 to B3) could be added with p to indicate coexisting perianal disease. Perianal disease (p) is defined as the presence of perianal abscesses or fistulae. |
| Sexual Quality of Life-Male (SQOL-M) Questionnaire Score for Male Participants | At inclusion visit (Day 1) | SQOL-M assessed the relationship between male sexual dysfunction and quality of life. It contains 11 items, each items are scored from 1 to 6 points (worst to best), completely agree = 1 to completely disagree = 6. The total score can range from 11 to 66 points. Higher scores indicate better male sexual quality of life. |
Countries
Portugal
Participant flow
Recruitment details
Data from participants were collected for this cross-sectional, observational study with a retrospective component at two investigative sites in Portugal from 9 July 2021 to 27 May 2022.
Pre-assignment details
Participants with a diagnosis of Crohn's disease (CD) with complex perianal fistulas (CPF) were enrolled from the investigative sites' database and were observed in a cross-sectional way along with a retrospective component to collect data for healthcare resource utilization and on the pharmacological and surgical treatments in this study.
Participants by arm
| Arm | Count |
|---|---|
| CD Participants With CPF Participants diagnosed with CD and CPF in the Portuguese routine clinical practice were assessed. Retrospective data on healthcare resource utilization related with CPF management in the previous three years was obtained from the medical records. | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | CD Participants With CPF | — |
|---|---|---|
| Age, Continuous | 44.40 years STANDARD_DEVIATION 12.39 | — |
| Body Mass Index (BMI) | 24.11 kg/meter^2 STANDARD_DEVIATION 4.11 | — |
| Height | 168.60 centimeter STANDARD_DEVIATION 8.28 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Portugal | 15 Participants | — |
| Sex: Female, Male Female | 8 Participants | — |
| Sex: Female, Male Male | 7 Participants | — |
| Weight | 68.45 kilogram (kg) STANDARD_DEVIATION 12.05 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 15 |
| other Total, other adverse events | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
Primary
Meta-Scores of the 12-Item Short Form Health Survey (SF-12) Questionnaire's Physical Component Score [PCS-12]
SF-12 is 12-item self-report that assesses physical and mental health related general quality of life (QoL) whose results are expressed in terms of two meta-scores: the physical component summary (PCS) and the mental component summary (MCS), of which the PCS component is presented in this outcome measure. The PCS score has a range of 0 to 100. Higher scores indicate better physical functioning.
Time frame: At inclusion visit (Day 1)
Population: All eligible participants with CD and CPAF were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CD Participants With CPF | Meta-Scores of the 12-Item Short Form Health Survey (SF-12) Questionnaire's Physical Component Score [PCS-12] | 45.36 score on a scale | Standard Deviation 7.58 |
Primary
Meta-Scores of the SF-12 Questionnaire's Mental Component Score [MCS-12])
SF-12 is 12-item self-report that assesses physical and mental health related general quality of life (QoL) whose results are expressed in terms of two meta-scores: the PCS and the MCS, of which the MCS component is presented in this outcome measure. The MCS score has a range of 0 to 100. Higher scores indicate better mental functioning.
Time frame: At inclusion visit (Day 1)
Population: All eligible participants with CD and CPAF were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CD Participants With CPF | Meta-Scores of the SF-12 Questionnaire's Mental Component Score [MCS-12]) | 38.00 score on a scale | Standard Deviation 8.48 |
Secondary
Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as Correlation Coefficient Stratified Based on Quantitative Variables
The following quantitative variables were considered for bivariate analysis: age, BMI, time between CD diagnosis date and date of study visit, total number of CPFs per participant, time between first CPF diagnosis date and date of study visit, PDAI score, number of internal and external fistula openings, time since seton placement, SIBDQ score, SQoL-M score (for male participants) and SQoL-F score (for female participants), and Wexner score. Data was collected and reported as number for all the quantitative variables as the associations (correlation coefficient) between general QoL and the quantitative variables was calculated using Spearman Correlation Coefficients.
Time frame: At inclusion visit (Day 1)
Population: All eligible participants with CD and CPAF were included in the analysis. Number analyzed is the number of participants with data available for analysis in the specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CD Participants With CPF | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as Correlation Coefficient Stratified Based on Quantitative Variables | MCS- 12: Age | 0.484 correlation coefficient |
| CD Participants With CPF | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as Correlation Coefficient Stratified Based on Quantitative Variables | MCS- 12: BMI | 0.022 correlation coefficient |
| CD Participants With CPF | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as Correlation Coefficient Stratified Based on Quantitative Variables | MCS- 12: Time Between CD Diagnosis Date and Date of Study Visit | -0.132 correlation coefficient |
| CD Participants With CPF | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as Correlation Coefficient Stratified Based on Quantitative Variables | MCS- 12: Total Number of CPFs per Participant | 0.077 correlation coefficient |
| CD Participants With CPF | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as Correlation Coefficient Stratified Based on Quantitative Variables | MCS- 12: Time Since Seton Placement | -0.323 correlation coefficient |
| CD Participants With CPF | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as Correlation Coefficient Stratified Based on Quantitative Variables | MCS- 12: Time Between First CPF Diagnosis Date and Date of Study Visit | -0.018 correlation coefficient |
| CD Participants With CPF | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as Correlation Coefficient Stratified Based on Quantitative Variables | MCS- 12: PDAI Score | 0.067 correlation coefficient |
| CD Participants With CPF | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as Correlation Coefficient Stratified Based on Quantitative Variables | MCS- 12: Number of Internal Fistula Openings per Participant | -0.207 correlation coefficient |
| CD Participants With CPF | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as Correlation Coefficient Stratified Based on Quantitative Variables | MCS- 12: Number of External Fistula Openings per Participant | -0.048 correlation coefficient |
| CD Participants With CPF | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as Correlation Coefficient Stratified Based on Quantitative Variables | MCS- 12: SIBDQ Score | 0.404 correlation coefficient |
| CD Participants With CPF | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as Correlation Coefficient Stratified Based on Quantitative Variables | MCS- 12: SQoL-M Score | 0.266 correlation coefficient |
| CD Participants With CPF | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as Correlation Coefficient Stratified Based on Quantitative Variables | MCS- 12: SQoL-F Score | 0.039 correlation coefficient |
| CD Participants With CPF | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as Correlation Coefficient Stratified Based on Quantitative Variables | MCS- 12: Wexner Score | -0.182 correlation coefficient |
Comparison: MCS- 12: Agep-value: =0.0674Pearson Correlation Coefficient
Comparison: MCS- 12: BMIp-value: =0.9392Pearson Correlation Coefficient
Comparison: MCS- 12: Time Between CD Diagnosis Date and Date of Study Visitp-value: =0.6387Spearman Correlation Coefficient
Comparison: MCS- 12: Total Number of CPFs per Participantp-value: =0.7846Spearman Correlation Coefficient
Comparison: MCS- 12: Time Since Seton Placementp-value: =0.3972Pearson Correlation Coefficient
Comparison: MCS- 12: Time Between First CPF Diagnosis Date and Date of Study Visitp-value: =0.9496Spearman Correlation Coefficient
Comparison: MCS- 12: PDAI Scorep-value: =0.813Pearson Correlation Coefficient
Comparison: MCS- 12: Number of Internal Fistula Openings per Participantp-value: =0.4588Spearman Correlation Coefficient
Comparison: MCS- 12: Number of External Fistula Openings per Participantp-value: =0.8663Spearman Correlation Coefficient
Comparison: MCS- 12: SIBDQ Scorep-value: =0.1349Pearson Correlation Coefficient
Comparison: MCS- 12: SQoL-M Scorep-value: =0.5647Pearson Correlation Coefficient
Comparison: MCS- 12: SQoL-F Scorep-value: =0.9509Pearson Correlation Coefficient
Comparison: MCS- 12: Wexner Scorep-value: =0.5328Pearson Correlation Coefficient
Secondary
Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables
The following qualitative variables were considered for the bivariate analysis: sex, smoking status, employment status, extraintestinal manifestations of Crohn's disease, Montreal classification for CD disease (age at onset, disease location, and disease behavior), fistula type and position, CD disease activity, treatment-naïve, surgery-naïve, type of surgery, and presence of seton, perianal abscess and anorectal stricture. MCS-12 scores were transformed to a 0 to 100, with higher scores indicating better quality of life.
Time frame: At inclusion visit (Day 1)
Population: All eligible participants with CD and CPAF were included in the analysis. Number analyzed is the number of participants with data available for analysis in the specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CD Participants With CPF | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables | MCS-12: Fistula With Midline Position- No | 33.63 score on a scale | Standard Deviation 11.63 |
| CD Participants With CPF | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables | MCS-12: Sex- Male | 36.27 score on a scale | Standard Deviation 5.6 |
| CD Participants With CPF | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables | MCS-12: Sex- Female | 39.51 score on a scale | Standard Deviation 10.56 |
| CD Participants With CPF | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables | MCS-12: Employment Status- Employed | 35.84 score on a scale | Standard Deviation 9.17 |
| CD Participants With CPF | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables | MCS-12: Employment Status- Unemployed | 41.22 score on a scale | Standard Deviation 7.89 |
| CD Participants With CPF | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables | MCS-12: Employment Status- Retired | 45.19 score on a scale | Standard Deviation 3.63 |
| CD Participants With CPF | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables | MCS-12: Employment Status- Student | 33.45 score on a scale | — |
| CD Participants With CPF | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables | MCS-12: Smoking Status- Never | 38.54 score on a scale | Standard Deviation 10.94 |
| CD Participants With CPF | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables | MCS-12: Smoking Status- Former | 31.97 score on a scale | Standard Deviation 2.62 |
| CD Participants With CPF | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables | MCS-12: Smoking Status- Current | 39.55 score on a scale | Standard Deviation 4.37 |
| CD Participants With CPF | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables | MCS-12: Age at Onset of CD Diagnosis- At or Below 16 Years | 30.11 score on a scale | — |
| CD Participants With CPF | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables | MCS-12: Age at Onset of CD Diagnosis- Between 17 and 40 Years | 36.73 score on a scale | Standard Deviation 8.55 |
| CD Participants With CPF | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables | MCS-12: Age at Onset of CD Diagnosis- Above 40 Years | 43.16 score on a scale | Standard Deviation 7.43 |
| CD Participants With CPF | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables | MCS-12: Disease Location 1- Terminal Ileum | 34.08 score on a scale | Standard Deviation 13.03 |
| CD Participants With CPF | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables | MCS-12: Disease Location 1 + 4- Terminal Ileum + Upper Gastrointestinal | 33.45 score on a scale | — |
| CD Participants With CPF | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables | MCS-12: Disease Location 2- Colon | 46.18 score on a scale | Standard Deviation 4.86 |
| CD Participants With CPF | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables | MCS-12: Disease Location 3- Ileocolon | 39.58 score on a scale | Standard Deviation 4.32 |
| CD Participants With CPF | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables | MCS-12: Disease Location 3 + 4- Ileocolon + Upper Gastrointestinal | 31.89 score on a scale | Standard Deviation 2.52 |
| CD Participants With CPF | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables | MCS-12: Disease Behavior- Nonstricturing, Nonpenetrating + Perianal | 39.35 score on a scale | Standard Deviation 7.19 |
| CD Participants With CPF | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables | MCS-12: Disease Behavior- Stricturing + Perianal | 34.05 score on a scale | Standard Deviation 11.26 |
| CD Participants With CPF | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables | MCS-12: Disease Behavior- Penetrating + Perianal | 42.51 score on a scale | Standard Deviation 2.35 |
| CD Participants With CPF | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables | MCS-12: Presence of any Extraintestinal Manifestation of CD- Yes | 38.80 score on a scale | Standard Deviation 2.74 |
| CD Participants With CPF | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables | MCS-12: Presence of any Extraintestinal Manifestation of CD- No | 37.88 score on a scale | Standard Deviation 9.12 |
| CD Participants With CPF | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables | MCS-12: Fistula With High Intersphincteric Type- Yes | 37.64 score on a scale | Standard Deviation 4.63 |
| CD Participants With CPF | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables | MCS-12: Fistula With High Intersphincteric Type- No | 38.09 score on a scale | Standard Deviation 9.36 |
| CD Participants With CPF | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables | MCS-12: Fistula With High Transsphincteric Type- Yes | 37.23 score on a scale | Standard Deviation 6.16 |
| CD Participants With CPF | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables | MCS-12: Fistula With High Transsphincteric Type- No | 38.20 score on a scale | Standard Deviation 9.19 |
| CD Participants With CPF | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables | MCS-12: Fistula With Suprasphincteric Type- Yes | 45.46 score on a scale | Standard Deviation 6.53 |
| CD Participants With CPF | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables | MCS-12: Fistula With Suprasphincteric Type- No | 36.85 score on a scale | Standard Deviation 8.35 |
| CD Participants With CPF | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables | MCS-12: Fistula With Extrasphincteric Type- Yes | 40.71 score on a scale | Standard Deviation 9.96 |
| CD Participants With CPF | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables | MCS-12: Fistula With Extrasphincteric Type- No | 37.58 score on a scale | Standard Deviation 8.62 |
| CD Participants With CPF | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables | MCS-12: Fistula With Superficial Type- No | 38.00 score on a scale | Standard Deviation 8.48 |
| CD Participants With CPF | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables | MCS-12: Fistula With Low Intersphincteric Type- Yes | 40.10 score on a scale | Standard Deviation 14.47 |
| CD Participants With CPF | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables | MCS-12: Fistula With Low Intersphincteric Type- No | 37.68 score on a scale | Standard Deviation 8.11 |
| CD Participants With CPF | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables | MCS-12: Fistula With Low Transsphincteric Type- Yes | 38.15 score on a scale | Standard Deviation 5.38 |
| CD Participants With CPF | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables | MCS-12: Fistula With Low Transsphincteric Type- No | 37.96 score on a scale | Standard Deviation 9.29 |
| CD Participants With CPF | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables | MCS-12: Fistula With Midline Position- Yes | 39.59 score on a scale | Standard Deviation 7.05 |
| CD Participants With CPF | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables | MCS-12: Fistula With Lateral Position- Yes | 36.33 score on a scale | Standard Deviation 9.95 |
| CD Participants With CPF | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables | MCS-12: Fistula With Lateral Position- No | 39.12 score on a scale | Standard Deviation 7.78 |
| CD Participants With CPF | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables | MCS-12: Fistula With Seton- Yes | 36.36 score on a scale | Standard Deviation 9.36 |
| CD Participants With CPF | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables | MCS-12: Fistula With Seton- No | 39.87 score on a scale | Standard Deviation 7.63 |
| CD Participants With CPF | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables | MCS-12: HBI Category- Remission | 37.15 score on a scale | Standard Deviation 8.66 |
| CD Participants With CPF | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables | MCS-12: HBI Category- Mild Activity | 45.40 score on a scale | Standard Deviation 6.6 |
| CD Participants With CPF | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables | MCS-12: HBI Category- Moderate Activity | 33.45 score on a scale | — |
| CD Participants With CPF | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables | MCS-12: Treatment-naïve- Yes | 36.47 score on a scale | — |
| CD Participants With CPF | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables | MCS-12: Treatment-naïve- No | 38.11 score on a scale | Standard Deviation 8.79 |
| CD Participants With CPF | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables | MCS-12: Surgery-naïve- Yes | 39.30 score on a scale | Standard Deviation 7.45 |
| CD Participants With CPF | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables | MCS-12: Surgery-naïve- No | 37.68 score on a scale | Standard Deviation 9 |
| CD Participants With CPF | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables | MCS-12: Surgery - Fistulotomy- Yes | 31.97 score on a scale | Standard Deviation 2.62 |
| CD Participants With CPF | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables | MCS-12: Surgery - Fistulotomy- No | 38.93 score on a scale | Standard Deviation 8.74 |
| CD Participants With CPF | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables | MCS-12: Surgery - Advancement Flap- No | 38.00 score on a scale | Standard Deviation 8.48 |
| CD Participants With CPF | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables | MCS-12: Surgery - LIFT- No | 38.00 score on a scale | Standard Deviation 8.48 |
| CD Participants With CPF | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables | MCS-12: Surgery - Fibrin Glue- No | 38.00 score on a scale | Standard Deviation 8.48 |
| CD Participants With CPF | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables | MCS-12: Surgery - Anal Fistula Plug- No | 38.00 score on a scale | Standard Deviation 8.48 |
| CD Participants With CPF | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables | MCS-12: Surgery - Defunctioning Stoma- No | 38.00 score on a scale | Standard Deviation 8.48 |
| CD Participants With CPF | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables | MCS-12: Surgery - Cutting Seton- No | 38.00 score on a scale | Standard Deviation 8.48 |
| CD Participants With CPF | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables | MCS-12: Surgery - Loose Seton- Yes | 39.81 score on a scale | Standard Deviation 9.46 |
| CD Participants With CPF | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables | MCS-12: Surgery - Loose Seton- No | 35.28 score on a scale | Standard Deviation 6.6 |
| CD Participants With CPF | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables | MCS-12: Surgery - Other- Yes | 46.80 score on a scale | Standard Deviation 3.98 |
| CD Participants With CPF | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables | MCS-12: Surgery - Other- No | 34.80 score on a scale | Standard Deviation 7.34 |
| CD Participants With CPF | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables | MCS-12: Presence of Perianal Abscess- Yes | 35.59 score on a scale | Standard Deviation 10.91 |
| CD Participants With CPF | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables | MCS-12: Presence of Perianal Abscess- No | 39.61 score on a scale | Standard Deviation 6.65 |
| CD Participants With CPF | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables | MCS-12: Presence of Anorectal Stricture- No | 38.00 score on a scale | Standard Deviation 8.48 |
Comparison: MCS-12: Sexp-value: =0.4814t-test for Independent Samples
Comparison: MCS-12: Employment Statusp-value: =0.3136Kruskal-Wallis
Comparison: MCS-12: Smoking Statusp-value: =0.5808ANOVA
Comparison: MCS-12: Age at Onsetp-value: =0.2965ANOVA
Comparison: MCS-12: Disease Locationp-value: =0.2874ANOVA
Comparison: MCS-12: Disease Behaviorp-value: =0.4269ANOVA
Comparison: MCS-12: Presence of any Extraintestinal Manifestation of CDp-value: =0.8931t-test for Independent Samples
Comparison: MCS-12: Fistula With High Intersphincteric Typep-value: =0.9384t-test for Independent Samples
Comparison: MCS-12: Fistula With High Transsphincteric Typep-value: =0.8286Mann-Whitney
Comparison: MCS-12: Fistula With Suprasphincteric Typep-value: =0.1919t-test for Independent Samples
Comparison: MCS-12: Fistula with Extrasphincteric Typep-value: =0.6452t-test for Independent Samples
Comparison: MCS-12: Fistula With Low Intersphincteric Typep-value: =0.7218t-test for Independent Samples
Comparison: MCS-12: Fistula With Low Transsphincteric Typep-value: =0.9738t-test for Independent Samples
Comparison: MCS-12: Fistula With Midline Positionp-value: =0.2419t-test for Independent Samples
Comparison: MCS-12: Fistula With Lateral Positionp-value: =0.5524t-test for Independent Samples
Comparison: MCS-12: Fistula With Setonp-value: =0.4443t-test for Independent Samples
Comparison: MCS-12: HBI Categories (Remission, Mild and Moderate Activity)p-value: =0.4106ANOVA
Comparison: MCS-12: Surgery-naïvep-value: =0.7795t-test for Independent Samples
Comparison: MCS-12: Surgery - Fistulotomyp-value: =0.2964t-test for Independent Samples
Comparison: MCS-12: Surgery - Loose Setonp-value: =0.3287t-test for Independent Samples
Comparison: MCS-12: Surgery - Otherp-value: =0.0091t-test for Independent Samples
Comparison: MCS-12: Presence of Perianal Abscessp-value: =0.3889t-test for Independent Samples
Secondary
Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as Correlation Coefficient Stratified Based on Quantitative Variables
The following quantitative variables were considered for bivariate analysis: age, BMI, time between CD diagnosis date and date of study visit, total number of CPFs per participant, time between first CPF diagnosis date and date of study visit, Perianal Disease Activity Index (PDAI) score, number of internal and external fistula openings, time since seton placement, SIBDQ score, SQoL-M score (for male participants) and SQoL-F score (for female participants), and Wexner score. Data was collected and reported as number for all the quantitative variables as the associations (correlation coefficient) between general QoL and the quantitative variables was calculated using Spearman Correlation Coefficients.
Time frame: At inclusion visit (Day 1)
Population: All eligible participants with CD and CPAF were included in the analysis. Number analyzed is the number of participants with data available for analysis in the specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CD Participants With CPF | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as Correlation Coefficient Stratified Based on Quantitative Variables | PCS- 12: Age | -0.072 correlation coefficient |
| CD Participants With CPF | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as Correlation Coefficient Stratified Based on Quantitative Variables | PCS- 12: BMI | 0.210 correlation coefficient |
| CD Participants With CPF | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as Correlation Coefficient Stratified Based on Quantitative Variables | PCS- 12: Time Between CD Diagnosis Date and Date of Study Visit | -0.014 correlation coefficient |
| CD Participants With CPF | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as Correlation Coefficient Stratified Based on Quantitative Variables | PCS- 12: Total Number of CPFs per Participant | -0.270 correlation coefficient |
| CD Participants With CPF | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as Correlation Coefficient Stratified Based on Quantitative Variables | PCS- 12: Time Since Seton Placement | -0.185 correlation coefficient |
| CD Participants With CPF | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as Correlation Coefficient Stratified Based on Quantitative Variables | PCS- 12: Time Between First CPF Diagnosis Date and Date of Study Visit | 0.071 correlation coefficient |
| CD Participants With CPF | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as Correlation Coefficient Stratified Based on Quantitative Variables | PCS- 12: PDAI Score | -0.707 correlation coefficient |
| CD Participants With CPF | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as Correlation Coefficient Stratified Based on Quantitative Variables | PCS - 12: Number of Internal Fistula Openings per Participant | -0.450 correlation coefficient |
| CD Participants With CPF | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as Correlation Coefficient Stratified Based on Quantitative Variables | PCS- 12: Number of External Fistula Openings per Participant | -0.442 correlation coefficient |
| CD Participants With CPF | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as Correlation Coefficient Stratified Based on Quantitative Variables | PCS- 12: SIBDQ Score | 0.525 correlation coefficient |
| CD Participants With CPF | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as Correlation Coefficient Stratified Based on Quantitative Variables | PCS- 12: SQoL-M Score | 0.690 correlation coefficient |
| CD Participants With CPF | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as Correlation Coefficient Stratified Based on Quantitative Variables | PCS- 12: SQoL-F Score | 0.046 correlation coefficient |
| CD Participants With CPF | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as Correlation Coefficient Stratified Based on Quantitative Variables | PCS- 12: Wexner Score | -0.259 correlation coefficient |
Comparison: PCS- 12: Agep-value: =0.8001Pearson Correlation Coefficient
Comparison: PCS- 12: BMIp-value: =0.4532Pearson Correlation Coefficient
Comparison: PCS- 12: Time Between CD Diagnosis Date and Date of Study Visitp-value: =0.9597Spearman Correlation Coefficient
Comparison: PCS- 12: Total Number of CPFs per Participantp-value: =0.3304Spearman Correlation Coefficient
Comparison: PCS- 12: Time Since Seton Replacementp-value: =0.6333Pearson Correlation Coefficient
Comparison: PCS- 12: Time Between First CPF Diagnosis Date and Date of Study Visitp-value: =0.8003Spearman Correlation Coefficient
Comparison: PCS- 12: PDAI Scorep-value: =0.0032Pearson Correlation Coefficient
Comparison: PCS- 12: Number of Internal Fistula Openings per Participantp-value: =0.0923Spearman Correlation Coefficient
Comparison: PCS- 12: Number of External Fistula Openings per Participantp-value: =0.0994Spearman Correlation Coefficient
Comparison: PCS- 12: SIBDQ Scorep-value: =0.0444Pearson Correlation Coefficient
Comparison: PCS- 12: SQoL-M Scorep-value: =0.086Pearson Correlation Coefficient
Comparison: PCS- 12: SQoL-F Scorep-value: =0.9415Pearson Correlation Coefficient
Comparison: PCS- 12: Wexner Scorep-value: =0.3709Pearson Correlation Coefficient
Secondary
Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables
The following qualitative variables were considered for the bivariate analysis: sex, smoking status, employment status, extraintestinal manifestations of Crohn's disease, Montreal classification for CD disease (age at onset, disease location, and disease behavior), fistula type and position, CD disease activity, treatment-naïve, surgery-naïve, type of surgery, and presence of seton, perianal abscess and anorectal stricture. PCS-12 scores were transformed to a 0 to 100, with higher scores indicating better quality of life.
Time frame: At inclusion visit (Day 1)
Population: All eligible participants with CD and CPAF were included in the analysis. Number analyzed is the number of participants with data available for analysis in the specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CD Participants With CPF | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables | PCS-12: Disease Location 2- Colon | 41.14 score on a scale | Standard Deviation 4.28 |
| CD Participants With CPF | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables | PCS-12: Sex- Male | 48.63 score on a scale | Standard Deviation 8.16 |
| CD Participants With CPF | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables | PCS-12: Sex- Female | 42.50 score on a scale | Standard Deviation 6.15 |
| CD Participants With CPF | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables | PCS-12: Employment Status- Employed | 44.01 score on a scale | Standard Deviation 7.33 |
| CD Participants With CPF | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables | PCS-12: Employment Status- Unemployed | 48.22 score on a scale | Standard Deviation 12.3 |
| CD Participants With CPF | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables | PCS-12: Employment Status- Retired | 48.18 score on a scale | Standard Deviation 3.49 |
| CD Participants With CPF | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables | PCS-12: Employment Status- Student | 43.25 score on a scale | — |
| CD Participants With CPF | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables | PCS-12: Smoking Status- Never | 47.90 score on a scale | Standard Deviation 7.66 |
| CD Participants With CPF | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables | PCS-12: Smoking Status- Former | 45.08 score on a scale | Standard Deviation 0.42 |
| CD Participants With CPF | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables | PCS-12: Smoking Status- Current | 41.40 score on a scale | Standard Deviation 8.12 |
| CD Participants With CPF | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables | PCS-12: Age at Onset of CD Diagnosis - At or Below 16 Years | 45.37 score on a scale | — |
| CD Participants With CPF | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables | PCS-12: Age at Onset of CD Diagnosis - Between 17 and 40 Years | 45.22 score on a scale | Standard Deviation 9.06 |
| CD Participants With CPF | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables | PCS-12: Age at Onset of CD Diagnosis - Above 40 Years | 45.70 score on a scale | Standard Deviation 4.7 |
| CD Participants With CPF | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables | PCS-12: Disease Location 1- Terminal Ileum | 54.14 score on a scale | Standard Deviation 4.46 |
| CD Participants With CPF | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables | PCS-12: Disease Location 1 + 4- Terminal Ileum + Upper Gastrointestinal | 43.25 score on a scale | — |
| CD Participants With CPF | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables | PCS-12: Disease Location 3- Ileocolon | 43.64 score on a scale | Standard Deviation 6.87 |
| CD Participants With CPF | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables | PCS-12: Disease Location 3 + 4- Ileocolon + Upper Gastrointestinal | 39.47 score on a scale | Standard Deviation 8.34 |
| CD Participants With CPF | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables | PCS-12: Disease Behavior- Nonstricturing, Nonpenetrating + Perianal | 44.25 score on a scale | Standard Deviation 7.33 |
| CD Participants With CPF | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables | PCS-12: Disease Behavior- Stricturing + Perianal | 47.61 score on a scale | Standard Deviation 9.16 |
| CD Participants With CPF | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables | PCS-12: Disease Behavior- Penetrating + Perianal | 44.15 score on a scale | Standard Deviation 7.4 |
| CD Participants With CPF | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables | PCS-12: Extraintestinal Manifestation of CD- Yes | 49.37 score on a scale | Standard Deviation 12.6 |
| CD Participants With CPF | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables | PCS-12: Extraintestinal Manifestation of CD- No | 44.74 score on a scale | Standard Deviation 7.13 |
| CD Participants With CPF | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables | PCS-12: Fistula With High Intersphincteric Type- Yes | 50.72 score on a scale | Standard Deviation 7.52 |
| CD Participants With CPF | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables | PCS-12: Fistula With High Intersphincteric Type- No | 44.02 score on a scale | Standard Deviation 7.29 |
| CD Participants With CPF | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables | PCS-12: Fistula With High Transsphincteric Type- Yes | 41.58 score on a scale | Standard Deviation 3.37 |
| CD Participants With CPF | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables | PCS-12: Fistula With High Transsphincteric Type- No | 46.30 score on a scale | Standard Deviation 8.14 |
| CD Participants With CPF | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables | PCS-12: Fistula With Suprasphincteric Type- Yes | 38.08 score on a scale | Standard Deviation 1.18 |
| CD Participants With CPF | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables | PCS-12: Fistula With Suprasphincteric Type- No | 46.48 score on a scale | Standard Deviation 7.54 |
| CD Participants With CPF | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables | PCS-12: Fistula With Extrasphincteric Type- Yes | 39.64 score on a scale | Standard Deviation 8.58 |
| CD Participants With CPF | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables | PCS-12: Fistula With Extrasphincteric Type- No | 46.24 score on a scale | Standard Deviation 7.39 |
| CD Participants With CPF | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables | PCS-12: Fistula With Superficial Type- No | 45.36 score on a scale | Standard Deviation 7.58 |
| CD Participants With CPF | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables | PCS-12: Fistula With Low Intersphincteric Type- Yes | 54.65 score on a scale | Standard Deviation 3.94 |
| CD Participants With CPF | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables | PCS-12: Fistula With Low Intersphincteric Type- No | 43.93 score on a scale | Standard Deviation 7.02 |
| CD Participants With CPF | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables | PCS-12: Fistula With Low Transsphincteric Type- Yes | 42.89 score on a scale | Standard Deviation 7.61 |
| CD Participants With CPF | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables | PCS-12: Fistula With Low Transsphincteric Type- No | 45.98 score on a scale | Standard Deviation 7.78 |
| CD Participants With CPF | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables | PCS-12: Fistula With Midline Position- Yes | 46.12 score on a scale | Standard Deviation 8.04 |
| CD Participants With CPF | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables | PCS-12: Fistula With Midline Position- No | 43.26 score on a scale | Standard Deviation 6.71 |
| CD Participants With CPF | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables | PCS-12: Fistula With Lateral Position- Yes | 43.77 score on a scale | Standard Deviation 6.43 |
| CD Participants With CPF | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables | PCS-12: Fistula With Lateral Position- No | 46.42 score on a scale | Standard Deviation 8.46 |
| CD Participants With CPF | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables | PCS-12: Fistula With Seton- Yes | 43.71 score on a scale | Standard Deviation 4.71 |
| CD Participants With CPF | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables | PCS-12: Fistula With Seton- No | 47.25 score on a scale | Standard Deviation 10.02 |
| CD Participants With CPF | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables | PCS-12: Harvey-Bradshaw Index (HBI) Category- Remission | 46.62 score on a scale | Standard Deviation 7.93 |
| CD Participants With CPF | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables | PCS-12: HBI Category- Mild Activity | 38.85 score on a scale | Standard Deviation 2.28 |
| CD Participants With CPF | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables | PCS-12: HBI Category- Moderate Activity | 43.25 score on a scale | — |
| CD Participants With CPF | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables | PCS-12: Treatment-naïve- Yes | 34.51 score on a scale | — |
| CD Participants With CPF | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables | PCS-12: Treatment-naïve- No | 46.13 score on a scale | Standard Deviation 7.23 |
| CD Participants With CPF | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables | PCS-12: Surgery-naïve- Yes | 37.93 score on a scale | Standard Deviation 6.75 |
| CD Participants With CPF | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables | PCS-12: Surgery-naïve- No | 47.22 score on a scale | Standard Deviation 6.79 |
| CD Participants With CPF | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables | PCS-12: Surgery - Fistulotomy- Yes | 45.08 score on a scale | Standard Deviation 0.42 |
| CD Participants With CPF | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables | PCS-12: Surgery - Fistulotomy- No | 45.40 score on a scale | Standard Deviation 8.19 |
| CD Participants With CPF | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables | PCS-12: Surgery - Advancement Flap- No | 45.36 score on a scale | Standard Deviation 7.58 |
| CD Participants With CPF | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables | PCS-12: Surgery - LIFT- No | 45.36 score on a scale | Standard Deviation 7.58 |
| CD Participants With CPF | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables | PCS-12: Surgery - Fibrin Glue- No | 45.36 score on a scale | Standard Deviation 7.58 |
| CD Participants With CPF | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables | PCS-12: Surgery - Anal Fistula Plug- No | 45.36 score on a scale | Standard Deviation 7.58 |
| CD Participants With CPF | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables | PCS-12: Surgery - Defunctioning Stoma- No | 45.36 score on a scale | Standard Deviation 7.58 |
| CD Participants With CPF | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables | PCS-12: Surgery - Cutting Seton- No | 45.36 score on a scale | Standard Deviation 7.58 |
| CD Participants With CPF | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables | PCS-12: Surgery - Loose Seton- Yes | 46.56 score on a scale | Standard Deviation 6.98 |
| CD Participants With CPF | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables | PCS-12: Surgery - Loose Seton- No | 43.56 score on a scale | Standard Deviation 8.76 |
| CD Participants With CPF | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables | PCS-12: Surgery - Other- Yes | 47.28 score on a scale | Standard Deviation 6.77 |
| CD Participants With CPF | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables | PCS-12: Surgery - Other- No | 44.66 score on a scale | Standard Deviation 8.05 |
| CD Participants With CPF | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables | PCS-12: Presence of Perianal Abscess- Yes | 47.57 score on a scale | Standard Deviation 7.88 |
| CD Participants With CPF | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables | PCS-12: Presence of Perianal Abscess- No | 43.88 score on a scale | Standard Deviation 7.47 |
| CD Participants With CPF | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables | PCS-12: Presence of Anorectal Stricture- No | 45.36 score on a scale | Standard Deviation 7.58 |
Comparison: PCS-12: Sexp-value: =0.1217t-test for Independent Samples
Comparison: PCS-12: Employment Statusp-value: =0.8241ANOVA
Comparison: PCS-12: Smoking Statusp-value: =0.3471ANOVA
Comparison: PCS-12: Age at Onsetp-value: =0.9951ANOVA
Comparison: PCS-12: Disease Locationp-value: =0.0631ANOVA
Comparison: PCS-12: Disease Behaviorp-value: =0.7473ANOVA
Comparison: PCS-12: Presence of any Extraintestinal Manifestation of CDp-value: =0.4422t-test for Independent Samples
Comparison: PCS-12: Fistula With High Intersphincteric Typep-value: =0.1796t-test for Independent Samples
Comparison: PCS-12: Fistula With High Transsphincteric Typep-value: =0.3535t-test for Independent Samples
Comparison: PCS-12: Fistula With Suprasphincteric Typep-value: =0.1508t-test for Independent Samples
Comparison: PCS-12: Fistula with Extrasphincteric Typep-value: =0.2671t-test for Independent Samples
Comparison: PCS-12: Fistula With Low Intersphincteric Typep-value: =0.0594t-test for Independent Samples
Comparison: PCS-12: Fistula With Low Transsphincteric Typep-value: =0.5484t-test for Independent Samples
Comparison: PCS-12: Fistula With Midline Positionp-value: =0.5387t-test for Independent Samples
Comparison: PCS-12: Fistula With Lateral Positionp-value: =0.527t-test for Independent Samples
Comparison: PCS-12: Fistula With Setonp-value: =0.3863t-test for Independent Samples
Comparison: PCS-12: HBI Categories (Remission, Mild and Moderate Activity)p-value: =0.4206ANOVA
Comparison: PCS-12: Surgery-naïvep-value: =0.0538t-test for Independent Samples
Comparison: PCS-12: Surgery - Fistulotomyp-value: =0.9572t-test for Independent Samples
Comparison: PCS-12: Surgery - Loose Setonp-value: =0.4742t-test for Independent Samples
Comparison: PCS-12: Surgery - Otherp-value: =0.5735t-test for Independent Samples
Comparison: PCS-12: Presence of Perianal Abscessp-value: =0.376t-test for Independent Samples
Secondary
Fecal Incontinence as Assessed by Wexner Score
Fecal incontinence is measured by Wexner score. It consists of five questions to assess the degree of incontinence (solid, liquid, gas, wears pad, lifestyle alteration). The frequency of each type of incontinence is rated on a scale ranging from 0 (never) to 4 (always or to once a day) so that the sum of the frequencies add up to a total score that ranges from 0 to 20. Higher scores indicate worse fecal incontinence.
Time frame: At inclusion visit (Day 1)
Population: All eligible participants with CD and CPAF were included in the analysis. Overall number analyzed is the number of participants with data available for analyses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CD Participants With CPF | Fecal Incontinence as Assessed by Wexner Score | 7.43 score on a scale | Standard Deviation 5.5 |
Secondary
Number of Participants Categorized Based on Sociodemographic and Anthropometric Characteristics
Sociodemographic and anthropometric variables included age (in years), sex (male or female), and body mass index (BMI).
Time frame: At inclusion visit (Day 1)
Population: All eligible participants with CD and CPAF were included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CD Participants With CPF | Number of Participants Categorized Based on Sociodemographic and Anthropometric Characteristics | BMI: Overweight | 4 Participants |
| CD Participants With CPF | Number of Participants Categorized Based on Sociodemographic and Anthropometric Characteristics | Sex: Male | 7 Participants |
| CD Participants With CPF | Number of Participants Categorized Based on Sociodemographic and Anthropometric Characteristics | Age: 22 to 64 Years | 15 Participants |
| CD Participants With CPF | Number of Participants Categorized Based on Sociodemographic and Anthropometric Characteristics | Sex: Female | 8 Participants |
| CD Participants With CPF | Number of Participants Categorized Based on Sociodemographic and Anthropometric Characteristics | BMI: Underweight | 0 Participants |
| CD Participants With CPF | Number of Participants Categorized Based on Sociodemographic and Anthropometric Characteristics | BMI: Normal range | 9 Participants |
| CD Participants With CPF | Number of Participants Categorized Based on Sociodemographic and Anthropometric Characteristics | BMI: Obese | 2 Participants |
Secondary
Number of Participants Characterized Based on Healthcare Resource Utilization (HCRU) Within Previous 3 Years
Number of participants characterized based on HCRU associated with complex perianal fistulas (CPFs) management within the three years prior to the inclusion visit were collected. HCRU includes gastroenterology and other medical specialty appointments for the management of CPF; emergency room visits due to CPF; hospitalizations (greater than or equal to \[\>=\] 24 hours) due to CPF, and intensive care unit (ICU) admission. Only categories with at least one participant with event are reported.
Time frame: Up to 3 years prior to the inclusion visit at Day 1
Population: All eligible participants with CD and CPAF were included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CD Participants With CPF | Number of Participants Characterized Based on Healthcare Resource Utilization (HCRU) Within Previous 3 Years | Any Medical Specialty Appointments for the Management of CPF | 15 Participants |
| CD Participants With CPF | Number of Participants Characterized Based on Healthcare Resource Utilization (HCRU) Within Previous 3 Years | Emergency Room Visits due to CPF | 3 Participants |
| CD Participants With CPF | Number of Participants Characterized Based on Healthcare Resource Utilization (HCRU) Within Previous 3 Years | Hospitalizations (>= 24 Hours) due to CPF | 5 Participants |
Secondary
Number of Participants Characterized Based on Pharmacological Treatments and Surgeries for CPF
For each pharmacological treatment (antibiotics, monoclonal antibodies, immunosuppressants, and others), participants were divided into three categories (current users, past users, and non-users) considering the three years prior to the inclusion visit. Surgical treatment in the last three years for the management of CPF was also recorded. A participant may be included in more than one category.
Time frame: Up to 3 years prior to the inclusion visit at Day 1
Population: All eligible participants with CD and CPAF were included in the analysis. Number analyzed is the number of participants with data available for analysis in the specified category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CD Participants With CPF | Number of Participants Characterized Based on Pharmacological Treatments and Surgeries for CPF | Non-users: Others | 15 Participants |
| CD Participants With CPF | Number of Participants Characterized Based on Pharmacological Treatments and Surgeries for CPF | Current Users: Antibiotics | 2 Participants |
| CD Participants With CPF | Number of Participants Characterized Based on Pharmacological Treatments and Surgeries for CPF | Current Users: Monoclonal Antibodies | 13 Participants |
| CD Participants With CPF | Number of Participants Characterized Based on Pharmacological Treatments and Surgeries for CPF | Current Users: Immunosuppressants | 7 Participants |
| CD Participants With CPF | Number of Participants Characterized Based on Pharmacological Treatments and Surgeries for CPF | Past Users: Antibiotics | 10 Participants |
| CD Participants With CPF | Number of Participants Characterized Based on Pharmacological Treatments and Surgeries for CPF | Past Users: Monoclonal Antibodies | 2 Participants |
| CD Participants With CPF | Number of Participants Characterized Based on Pharmacological Treatments and Surgeries for CPF | Past Users: Immunosuppressants | 2 Participants |
| CD Participants With CPF | Number of Participants Characterized Based on Pharmacological Treatments and Surgeries for CPF | Non-users: Antibiotics | 5 Participants |
| CD Participants With CPF | Number of Participants Characterized Based on Pharmacological Treatments and Surgeries for CPF | Non-users: Monoclonal Antibodies | 2 Participants |
| CD Participants With CPF | Number of Participants Characterized Based on Pharmacological Treatments and Surgeries for CPF | Non-users: Immunosuppressants | 7 Participants |
| CD Participants With CPF | Number of Participants Characterized Based on Pharmacological Treatments and Surgeries for CPF | Surgical Treatment in the Last Three Years for the Management of CPF- Yes | 11 Participants |
| CD Participants With CPF | Number of Participants Characterized Based on Pharmacological Treatments and Surgeries for CPF | Surgical Treatment in the Last Three Years for the Management of CPF- No | 1 Participants |
Secondary
Number of Participants With Moderate to Severe Crohn's Disease (CD) Stratified by Clinical Characteristics
The Montreal classification index for CD is used to classify the extent of the disease activity. It consists of two parameters: location and behavior of the disease activity. There are four different disease locations presented: Location 1 (L1) is ileum, Location 2 (L2) is colonic disease, Location 3 (L3) is ileocolon and Location 4 (L4) is isolated upper gastrointestinal (GI) tract disease. The first three categories (L1-L3) is combined with L4 where disease sites coexisted. There are 4 different categories for the behavior of the disease activity: Behavior 1 (B1) is non stenosing or non penetrating; Behavior 2 (B2) was stenosing; Behavior 3 (B3) is penetrating and p as perianal disease (p). The first 3 categories (B1 to B3) could be added with p to indicate coexisting perianal disease. Perianal disease (p) is defined as the presence of perianal abscesses or fistulae.
Time frame: At inclusion visit (Day 1)
Population: All eligible participants with CD and CPAF were included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CD Participants With CPF | Number of Participants With Moderate to Severe Crohn's Disease (CD) Stratified by Clinical Characteristics | Disease Location 1: Terminal Ileum | 4 Participants |
| CD Participants With CPF | Number of Participants With Moderate to Severe Crohn's Disease (CD) Stratified by Clinical Characteristics | Disease Location 1 + 4: Terminal Ileum + Upper Gastrointestinal | 1 Participants |
| CD Participants With CPF | Number of Participants With Moderate to Severe Crohn's Disease (CD) Stratified by Clinical Characteristics | Disease Location 2: Colon | 3 Participants |
| CD Participants With CPF | Number of Participants With Moderate to Severe Crohn's Disease (CD) Stratified by Clinical Characteristics | Disease Location 3: Ileocolon | 5 Participants |
| CD Participants With CPF | Number of Participants With Moderate to Severe Crohn's Disease (CD) Stratified by Clinical Characteristics | Disease Location 3 + 4: Ileocolon + Upper Gastrointestinal | 2 Participants |
| CD Participants With CPF | Number of Participants With Moderate to Severe Crohn's Disease (CD) Stratified by Clinical Characteristics | Disease Behavior, Perianal Disease B1p: Nonstricturing, Nonpenetrating + Perianal | 8 Participants |
| CD Participants With CPF | Number of Participants With Moderate to Severe Crohn's Disease (CD) Stratified by Clinical Characteristics | Disease Behavior, Perianal Disease B2p: Stricturing + Perianal | 5 Participants |
| CD Participants With CPF | Number of Participants With Moderate to Severe Crohn's Disease (CD) Stratified by Clinical Characteristics | Disease Behavior, Perianal Disease B3p: Penetrating + Perianal | 2 Participants |
Secondary
Sexual Quality of Life-Female (SQOL-F) Questionnaire Score for Female Participants
SQOL-F assessed the relationship between female sexual dysfunction and quality of life. It consists of 18 items, rated using a six-point scale (completely agree to completely disagree). The total score can range from 18 to 108 points. Higher scores indicate better female sexual quality of life.
Time frame: At inclusion visit (Day 1)
Population: All eligible female participants with CD and CPAF with data available for analyses were included and are presented as the overall number of participants analyzed in this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CD Participants With CPF | Sexual Quality of Life-Female (SQOL-F) Questionnaire Score for Female Participants | 72.80 score on a scale | Standard Deviation 25.54 |
Secondary
Sexual Quality of Life-Male (SQOL-M) Questionnaire Score for Male Participants
SQOL-M assessed the relationship between male sexual dysfunction and quality of life. It contains 11 items, each items are scored from 1 to 6 points (worst to best), completely agree = 1 to completely disagree = 6. The total score can range from 11 to 66 points. Higher scores indicate better male sexual quality of life.
Time frame: At inclusion visit (Day 1)
Population: All eligible male participants with CD and CPAF were included in the analysis and are presented as the overall number of participants analyzed in this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CD Participants With CPF | Sexual Quality of Life-Male (SQOL-M) Questionnaire Score for Male Participants | 44.57 score on a scale | Standard Deviation 14.59 |
Secondary
Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Score
The SIBDQ is an instrument used to assess QoL and is a disease-specific health-related quality of life questionnaire, that consists of 10 questions, each question is scored on a scale from 1 (poor quality of life) to 7 (good quality of life). The total score is reported and ranges from 10 to 70 with a higher score indicating a better health-related QoL.
Time frame: At inclusion visit (Day 1)
Population: All eligible participants with CD and CPAF were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CD Participants With CPF | Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Score | 45.00 score on a scale | Standard Deviation 10.72 |
Secondary
Work Productivity and Activity Impairment (WPAI) as Assessed by WPAI Questionnaire Score
WPAI score was used to describe the indirect healthcare resources. It is self-administered 6-item questionnaire (scale of 0-10) which assesses the effect of disease on work productivity in the past 7 days obtained for absenteeism (work time missed), presenteeism (impairment at work / reduced on-the-job effectiveness), work productivity loss (overall work impairment / absenteeism plus presenteeism) and activity impairment / disability. Scores are presented as percentages (multiplying the scores by 100), Domain scores are expressed as a percentage, with a range of scores form 0-100%, with 0% representing no impact on productivity and 100% representing complete impact on productivity. Higher scores indicate greater impairment.
Time frame: At inclusion visit (Day 1)
Population: All eligible participants with CD and CPAF were included in the analysis. Number analyzed is the number of participants with data available for analysis in the specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CD Participants With CPF | Work Productivity and Activity Impairment (WPAI) as Assessed by WPAI Questionnaire Score | Absenteeism | 3.80 score on a scale | Standard Deviation 6.85 |
| CD Participants With CPF | Work Productivity and Activity Impairment (WPAI) as Assessed by WPAI Questionnaire Score | Presenteeism | 57.78 score on a scale | Standard Deviation 29.91 |
| CD Participants With CPF | Work Productivity and Activity Impairment (WPAI) as Assessed by WPAI Questionnaire Score | Work Productivity Loss | 58.89 score on a scale | Standard Deviation 30.28 |
| CD Participants With CPF | Work Productivity and Activity Impairment (WPAI) as Assessed by WPAI Questionnaire Score | Activity Impairment | 52.67 score on a scale | Standard Deviation 31.27 |