Chronic Constipation, Intussusception, Obstructive Defecation Syndrome, Rectocele
Conditions
Keywords
Obstructive Defecation Syndrome, Colorectal Surgery, Defecography, Constipation, Rectocele, Intussusception, Quality of Life
Brief summary
The primary purpose of this study is to determine how effective and how durable STARR (stapled transanal rectal resection) surgery is in relieving symptoms of intractable constipation associated with obstructive defecation syndrome (ODS).
Detailed description
Rectocele and rectal intussusception are frequent findings in women but are often asymptomatic apart from anatomical defects, which can be seen on vaginal examination. They can be associated, however, with refractory constipation that may be best described by the terms Outlet Obstruction or Obstructive Defecation Syndrome (ODS). ODS is characterized by a symptom complex, including the feeling of incomplete evacuation associated with the need to strain excessively and for external assistance (digital, mechanical or positional maneuvers, enemas or suppositories) to aid defecation. Abdominal or rectal pain is also a common complaint. Obstetric trauma is also recognized as a contributing factor. However, none of these symptoms/factors can be singled out to be pathognomonic for this problem. ODS has a prevalence of approximately 12% in the general population. For individuals with ODS and related intussusception/rectocele, a variety of surgical techniques including abdominal, vaginal, transanal and perineal approaches have been devised. The impact of clinical studies to evaluate these techniques has been limited by variability of results and lack of comparators. Recently, a new surgical approach was developed by an Italian surgeon, A. Longo, and has been evaluated in several European centers. These early studies and observations indicate that this new procedure may in fact provide significantly better symptom resolution in ODS patients than other available treatments, and warrants further study. The procedure is referred to as Stapled Transanal Rectal Resection (STARR) and this study will assess its effectiveness in a United States population.
Interventions
PROCEDUREStapled Transanal Resection (STARR) with Transtar (PROXIMATE®) 33 mm Circular Stapler
Sponsors
Ethicon Endo-Surgery
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Able to comprehend, understand, and speak the English language * Able to comprehend, follow, and sign an informed consent document (ICD) * Able to tolerate general or spinal anesthetic * Often experience excessive straining, sense of incomplete evacuation, and/or prolonged time for complete evacuation when attempting a bowel movement * Have experienced ODS symptoms for at least 12 months prior to enrollment * Have a minimum ODS score of 10 * Have rectocele and/or rectal intussusception confirmed by defecography * Screened for colorectal neoplasia within 7 years of the screening visit (e.g., colonoscopy or barium enema) * Have an American Society of Anesthesiologists (ASA) score of no more than 3 * Willing to comply with evaluation and management schedule through 5-year follow-up
Exclusion criteria
* Fecal incontinence to solid stool * Full-thickness prolapse * Perineal infection * Recto-vaginal fistula * Enterocele (at rest) * Any complex pelvic floor prolapse requiring a combined surgical approach * Prior sigmoid or anterior resection or prior rectal anastomosis * Presence of foreign material adjacent to the rectum (e.g., vaginal mesh) * Grade IV hemorrhoids * Pregnancy * Chronic narcotic use * Evidence of colorectal neoplasia, carcinoma, or inflammatory bowel disease * Physical or psychological condition which would impair study participation * Unable or unwilling to attend follow-up visits and examinations * Surgical procedure required concurrently with STARR * Prior pelvic radiotherapy * Failure to identify any anatomical or physiological abnormality in the evaluation * Significant rectal fibrosis * Anal stenosis precluding insertion of the stapling device * Participation in any other investigational device or drug study 30 days prior to enrollment * Presence or history of hepatitis B, hepatitis C, and/or HIV positive test
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Change (Reduction) in Total ODS Symptom Composite Score From Baseline to One Year Post Procedure | one year from Baseline | The primary endpoint used to assess effectiveness of STARR for treatment of ODS was the percentage of change in total ODS symptom composite score (0=worst, 24=best) 1 year after completion of the procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Change in Subject-reported Assessment of Symptom Severity and Frequency (PAC SYM). | Baseline, 6 months | Assessed as patient-reported assessment of symptom severity and frequency (PAC-SYM)associated with constipation. Patient response options are absent, mild, moderate, severe, and very severe.12 questions relate to severity, 8 questions relate to frequency of symptoms. The lower the score, the less severe the symptoms. Sizing consistent with primary outcome; analysis was per-protocol. |
| Percentage of Change in ODS Symptom Composite Score From Baseline at 6 Months (0 is Worst Score, 24 is Best Score) | Baseline, 6 months post procedure | The primary endpoint used to assess effectiveness of STARR for treatment of ODS was the percentage of change in total ODS symptom composite score (0=worst, 24=best) 1 year after completion of the procedure. |
| Percentage of Change in ODS Symptom Composite Score From Baseline at 1 Month Post Procedure | Baseline, 1 month post procedure | Percentage of change in Obstructive Defecation Syndrome (ODS) symptom composite score from baseline at 1 month post procedure. This score is based on a series of questions designed to understand the extent ODS effects an individual's daily lifestyle (0 is worst score, 24 is best score). Sizing consistent with primary outcome; analysis was per-protocol. |
| SF-12 QOL Change From Baseline (Physical Component)at 12 Months | Baseline, 12 Months | The SF-12 is a validated 12 question quality-of-life questionnaire. The SF-12 extracts 12 items from the SF-36 questionnaire in two six-item subscales, PCS (physical functioning) and MCS (emotional functioning). The SF-12 scores can range from 10 (maximum impairment) to 70 (no impairment). For this study, the endpoint is the percentage of change from baseline over 12 months post procedure. |
| SF-12 QOL Change (Mental Component) at 12 Months From Baseline | Baseline, 12 months | SF 12 change from baseline, mental component. The SF-12 is a validated 12 question quality-of-life questionnaire. The SF-12 extracts 12 items from the SF-36 questionnaire in two six-item subscales, PCS (physical functioning) and MCS (emotional functioning). The SF-36 scores range from 0 (maximum impairment) to 100 (no impairment), the SF-12 scores range from 10 (maximum impairment) to 70 (no impairment). For this study, the endpoint is the percentage of change from baseline over 12 months post procedure. |
| PAC QOL Patient Assessment of Constipation (Overall) | Baseline, 12 months | PAC-QOL is Patient Assessment of Constipation, Quality of Life. The instrument consists of 28 questions on a 0-4 scale. A lower score indicates better quality of life. The score is a number without units.Change from baseline in patient assessment of constipation in quality of life as measured by the PAC QOL instrument score. The questions are designed to measure the impact constipation has had on daily life during the week prior to the subject visit. Sizing was consistent with the primary outcome; analysis was per-protocol |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Stapled Trans-Anal Rectal Resection (STARR) STARR procedure (an anterior and posterior, full-thickness stapling and resection of the rectal wall) to correct Obstructive Defecation Syndrome symptoms utilizing the TransStar Circular Stapler | 75 |
| Total | 75 |
Baseline characteristics
| Characteristic | Stapled Trans-Anal Rectal Resection (STARR) |
|---|---|
| Age, Continuous | 48 years |
| number of subjects in each age range having STARR procedure <=29 years | 4 participants |
| number of subjects in each age range having STARR procedure >=70 years | 7 participants |
| number of subjects in each age range having STARR procedure Between 30 and 39 years | 9 participants |
| number of subjects in each age range having STARR procedure Between 40 and 49 years | 26 participants |
| number of subjects in each age range having STARR procedure Between 50 and 59 years | 18 participants |
| number of subjects in each age range having STARR procedure Between 60 and 69 years | 11 participants |
| ODS composite score | 6.19 units on a scale STANDARD_DEVIATION 3.13 |
| Sex: Female, Male Female | 75 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 33 / 75 |
| serious Total, serious adverse events | 14 / 75 |
Outcome results
Primary
Percentage of Change (Reduction) in Total ODS Symptom Composite Score From Baseline to One Year Post Procedure
The primary endpoint used to assess effectiveness of STARR for treatment of ODS was the percentage of change in total ODS symptom composite score (0=worst, 24=best) 1 year after completion of the procedure.
Time frame: one year from Baseline
Population: Per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stapled Trans-Anal Rectal Resection (STARR) | Percentage of Change (Reduction) in Total ODS Symptom Composite Score From Baseline to One Year Post Procedure | 60.8 percentage of change | Standard Deviation 35.46 |
Secondary
Maximum Change in Subject-reported Assessment of Symptom Severity and Frequency (PAC SYM).
Assessed as patient-reported assessment of symptom severity and frequency (PAC-SYM)associated with constipation. Patient response options are absent, mild, moderate, severe, and very severe.12 questions relate to severity, 8 questions relate to frequency of symptoms. The lower the score, the less severe the symptoms. Sizing consistent with primary outcome; analysis was per-protocol.
Time frame: Baseline, 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stapled Trans-Anal Rectal Resection (STARR) | Maximum Change in Subject-reported Assessment of Symptom Severity and Frequency (PAC SYM). | 1.43 units on a scale | Standard Deviation 0.72 |
Secondary
PAC QOL Patient Assessment of Constipation (Overall)
PAC-QOL is Patient Assessment of Constipation, Quality of Life. The instrument consists of 28 questions on a 0-4 scale. A lower score indicates better quality of life. The score is a number without units.Change from baseline in patient assessment of constipation in quality of life as measured by the PAC QOL instrument score. The questions are designed to measure the impact constipation has had on daily life during the week prior to the subject visit. Sizing was consistent with the primary outcome; analysis was per-protocol
Time frame: Baseline, 12 months
Population: Sizing consistent with primary outcome; analysis was Intent-to-Treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stapled Trans-Anal Rectal Resection (STARR) | PAC QOL Patient Assessment of Constipation (Overall) | 0.95 units on a scale | Standard Deviation 0.996 |
Secondary
Percentage of Change in ODS Symptom Composite Score From Baseline at 1 Month Post Procedure
Percentage of change in Obstructive Defecation Syndrome (ODS) symptom composite score from baseline at 1 month post procedure. This score is based on a series of questions designed to understand the extent ODS effects an individual's daily lifestyle (0 is worst score, 24 is best score). Sizing consistent with primary outcome; analysis was per-protocol.
Time frame: Baseline, 1 month post procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stapled Trans-Anal Rectal Resection (STARR) | Percentage of Change in ODS Symptom Composite Score From Baseline at 1 Month Post Procedure | -50.7 percentage of change | Standard Deviation 34.4 |
Secondary
Percentage of Change in ODS Symptom Composite Score From Baseline at 6 Months (0 is Worst Score, 24 is Best Score)
The primary endpoint used to assess effectiveness of STARR for treatment of ODS was the percentage of change in total ODS symptom composite score (0=worst, 24=best) 1 year after completion of the procedure.
Time frame: Baseline, 6 months post procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stapled Trans-Anal Rectal Resection (STARR) | Percentage of Change in ODS Symptom Composite Score From Baseline at 6 Months (0 is Worst Score, 24 is Best Score) | -57.0 percentage of change | Standard Deviation 34.4 |
Secondary
SF-12 QOL Change From Baseline (Physical Component)at 12 Months
The SF-12 is a validated 12 question quality-of-life questionnaire. The SF-12 extracts 12 items from the SF-36 questionnaire in two six-item subscales, PCS (physical functioning) and MCS (emotional functioning). The SF-12 scores can range from 10 (maximum impairment) to 70 (no impairment). For this study, the endpoint is the percentage of change from baseline over 12 months post procedure.
Time frame: Baseline, 12 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stapled Trans-Anal Rectal Resection (STARR) | SF-12 QOL Change From Baseline (Physical Component)at 12 Months | 6.32 units on a scale | Standard Deviation 9.106 |
Secondary
SF-12 QOL Change (Mental Component) at 12 Months From Baseline
SF 12 change from baseline, mental component. The SF-12 is a validated 12 question quality-of-life questionnaire. The SF-12 extracts 12 items from the SF-36 questionnaire in two six-item subscales, PCS (physical functioning) and MCS (emotional functioning). The SF-36 scores range from 0 (maximum impairment) to 100 (no impairment), the SF-12 scores range from 10 (maximum impairment) to 70 (no impairment). For this study, the endpoint is the percentage of change from baseline over 12 months post procedure.
Time frame: Baseline, 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stapled Trans-Anal Rectal Resection (STARR) | SF-12 QOL Change (Mental Component) at 12 Months From Baseline | 4.83 units on a scale | Standard Deviation 11.67 |