Low Anterior Resection Syndrome
Conditions
Brief summary
Objective The primary objective is to demonstrate superiority of the Peristeen cone catheter compared to standard of care. The secondary objective is to investigate quality of life and different benefits and aspects of treatment and satisfaction with the Peristeen cone catheter. Design of the investigation This is a randomised, open-label, parallel investigation comparing the Peristeen cone catheter with standard of care in subjects with major LARS (LARS score ≥ 30). Each subject will be enrolled for a study duration of 12 weeks. Subjects will be randomized to the treatments stratified by neo-adjuvant radiotherapy. The comparator in this study will be current standard of care for patients with LARS which is conservative bowel management. This is defined as: Supportive therapy according to the individual treatment protocols available at each participating site. Primary endpoint and secondary endpoints Primary endpoint: • LARS score, obtained from the LARS score questionnaire\* Secondary endpoints: * Number of subjects with Major LARS\* * FIQL Score - scale 1, Modified American Society for Colorectal Surgeons Questionnaire\* * FIQL Score - scale 2, Modified American Society for Colorectal Surgeons Questionnaire\* * FIQL Score - scale 3, Modified American Society for Colorectal Surgeons Questionnaire\* * FIQL Score - scale 4, Modified American Society for Colorectal Surgeons Questionnaire\* * EQ-5D-5L - utility score\* * EQ-5D-5L - VAS score (scale 0-10 cm)\* * Satisfaction with treatment (scale 0-10 cm)\* * Number of adverse events\* \*All endpoints are measured per subject at study completion
Interventions
DEVICEPeristeen cone catheter
The active intervention is the Peristeen cone catheter device. The comparator in this investigation is current standard of care for patients with LARS which is conservative bowel management.
Sponsors
MedPass International
Coloplast A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. Be at least 18 years of age and have full legal Capacity 2. Have given written informed consent 3. Be mental and physical capable to perform transanal irrigation with cone catheter 4. Have a LARS score ≥ 30 after rectal resection 5. Be treated according to individual treatment protocol for conservatory bowel management at participating site 6. Have proof of complete healing of the anastomosis by endoscopy or radiology before stoma closure 7. At least 3-months from last surgery in colorectum 8. Be evaluated to be suitable for transanal Irrigation procedure with a cone catheter by endoscopy, defecography or comparable procedure
Exclusion criteria
1. Active/recurrent colorectal cancer 2. Leaking anastomosis 3. Known anal or colorectal stenosis 4. Within 4 weeks of endoscopic polypectomy 5. Ischaemic colitis 6. Acute inflammatory bowel disease 7. Acute diverticulitis 8. Current or planned pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LARS Score | Total score measured per subject at study completion after 12 weeks | Obtained from the LARS score questionnaire on a scale from 0-42 in total score. Subscores are summed to get the total score. With 0 indicating lowest score and 42 highest score. 0-20 indicate No LARS, 21-29 minor LARS, 30-42 Major LARS. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Major LARS | 12 weeks | Obtained from the LARS score questionnaire on a scale from 0-42 in total score. Subscores are summed to get the total score. With 0 indicating lowest score and 42 highest score. 0-20 indicate No LARS, 21-29 minor LARS, 30-42 Major LARS. |
| FIQL Score - Scale 1 Lifestyle, Modified American Society for Colorectal Surgeons Questionnaire | 12 weeks | The FIQL scale was thus interpreted for four scales exploring different aspects of the patient's quality-of-life. the Fecal Incontinence Quality of Life Scale (FIQL) contains 29 questions, across 4 domains, lifestyle (10 questions), Coping/Behavior (9 questions), Depression/Self Perception (7 questions), Embarrassment (3 questions). Items were scored 1 (least satisfactory quality-of-life) to 4 (most satisfactory quality-of-life) Results are reported as a Scale score which is the average (mean) response to all items in the scale (e.g., add the responses to all questions in a scale together and then divide by the number of items in the scale). |
| FIQL Score - Scale 2 Coping/Behavior, Modified American Society for Colorectal Surgeons Questionnaire | 12 weeks | The FIQL scale was thus interpreted for four scales exploring different aspects of the patient's quality-of-life. the Fecal Incontinence Quality of Life Scale (FIQL) contains 29 questions, across 4 domains, lifestyle (10 questions), Coping/Behavior (9 questions), Depression/Self Perception (7 questions), Embarrassment (3 questions). Items were scored 1 (least satisfactory quality-of-life) to 4 (most satisfactory quality-of-life) Results are reported as a Scale score which is the average (mean) response to all items in the scale (e.g., add the responses to all questions in a scale together and then divide by the number of items in the scale). |
| Satisfaction With Treatment | 12 weeks | Satisfaction with current bowel management treatment on a scale from 0 (total dissatisfaction) to 10 (perfect satisfaction) rated on a VAS scale from 0 to 10 cm. |
| FIQL Score - Scale 4 Embarrassment , Modified American Society For Colorectal Surgeons Questionnaire | 12 weeks | The FIQL scale was thus interpreted for four scales exploring different aspects of the patient's quality-of-life. the Fecal Incontinence Quality of Life Scale (FIQL) contains 29 questions, across 4 domains, lifestyle (10 questions), Coping/Behavior (9 questions), Depression/Self Perception (7 questions), Embarrassment (3 questions). Items were scored 1 (least satisfactory quality-of-life) to 4 (most satisfactory quality-of-life) Results are reported as a Scale score which is the average (mean) response to all items in the scale (e.g., add the responses to all questions in a scale together and then divide by the number of items in the scale). |
| EQ-5D-5L - Utility Score | 12 weeks | Each of the five dimensions comprising the EQ-5D descriptive system (mobility, self-care, usual activates, pain/discomfort, anxiety/depression) was divided into five levels: 1. no problem 2. slight problems 3. moderate problems 4. severe problems 5. unable to/extreme problems A unique health state was defined by combining one level from each of the five dimensions. i.e. state 12345 each state referred to by a 5-digit code was mapped into a utility score. Values are anchored at 1 (full health) and 0 (a state as bad as being dead) as required by their use in economic evaluation. Values less than 0 represent health states regarded as worse than a state that is as bad as being dead. EQ-5D-5L health states are converted into a single index 'utility' score using a scoring algorithm based on public preferences. Potential values from this algorithm can range from minus scores up to 1, in this case -0.525 to 1. |
| EQ-5D-5L - VAS Score | 12 weeks | The EQ VAS records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'. The VAS scale is from 0 to 100 with 0 indicating worst health and 100 best health possible. |
| FIQL Score - Scale 3 Depression/Self-perception, Modified American Society for Colorectal Surgeons Questionnaire | 12 weeks | The FIQL scale was thus interpreted for four scales exploring different aspects of the patient's quality-of-life. the Fecal Incontinence Quality of Life Scale (FIQL) contains 29 questions, across 4 domains, lifestyle (10 questions), Coping/Behavior (9 questions), Depression/Self Perception (7 questions), Embarrassment (3 questions). Items were scored 1 (least satisfactory quality-of-life) to 4 (most satisfactory quality-of-life) Results are reported as a Scale score which is the average (mean) response to all items in the scale (e.g., add the responses to all questions in a scale together and then divide by the number of items in the scale). |
Countries
Denmark
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Peristeen Subjects to use newly developed Peristeen cone catherter device | 15 |
| Standard of Care Subjects continue with their standard of care treatment which is conservative bowel management. | 15 |
| Total | 30 |
Baseline characteristics
| Characteristic | Standard of Care | Total | Peristeen |
|---|---|---|---|
| Age, Continuous | 62.9 Years STANDARD_DEVIATION 10.1 | 63.1 Years STANDARD_DEVIATION 11.4 | 63.3 Years STANDARD_DEVIATION 12.9 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment France | 15 participants | 30 participants | 15 participants |
| Sex: Female, Male Female | 6 Participants | 8 Participants | 2 Participants |
| Sex: Female, Male Male | 9 Participants | 22 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 16 |
| other Total, other adverse events | 5 / 16 | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 | 0 / 16 |
Outcome results
Primary
LARS Score
Obtained from the LARS score questionnaire on a scale from 0-42 in total score. Subscores are summed to get the total score. With 0 indicating lowest score and 42 highest score. 0-20 indicate No LARS, 21-29 minor LARS, 30-42 Major LARS.
Time frame: Total score measured per subject at study completion after 12 weeks
Population: Missing data from 1 standard of care patient
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Peristeen | LARS Score | 21.3 score on a scale |
| Standard of Care | LARS Score | 32.2 score on a scale |
Secondary
EQ-5D-5L - Utility Score
Each of the five dimensions comprising the EQ-5D descriptive system (mobility, self-care, usual activates, pain/discomfort, anxiety/depression) was divided into five levels: 1. no problem 2. slight problems 3. moderate problems 4. severe problems 5. unable to/extreme problems A unique health state was defined by combining one level from each of the five dimensions. i.e. state 12345 each state referred to by a 5-digit code was mapped into a utility score. Values are anchored at 1 (full health) and 0 (a state as bad as being dead) as required by their use in economic evaluation. Values less than 0 represent health states regarded as worse than a state that is as bad as being dead. EQ-5D-5L health states are converted into a single index 'utility' score using a scoring algorithm based on public preferences. Potential values from this algorithm can range from minus scores up to 1, in this case -0.525 to 1.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Peristeen | EQ-5D-5L - Utility Score | 0.92 score on a scale |
| Standard of Care | EQ-5D-5L - Utility Score | 0.88 score on a scale |
Secondary
EQ-5D-5L - VAS Score
The EQ VAS records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'. The VAS scale is from 0 to 100 with 0 indicating worst health and 100 best health possible.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Peristeen | EQ-5D-5L - VAS Score | 82.8 score on a scale |
| Standard of Care | EQ-5D-5L - VAS Score | 71.4 score on a scale |
Secondary
FIQL Score - Scale 1 Lifestyle, Modified American Society for Colorectal Surgeons Questionnaire
The FIQL scale was thus interpreted for four scales exploring different aspects of the patient's quality-of-life. the Fecal Incontinence Quality of Life Scale (FIQL) contains 29 questions, across 4 domains, lifestyle (10 questions), Coping/Behavior (9 questions), Depression/Self Perception (7 questions), Embarrassment (3 questions). Items were scored 1 (least satisfactory quality-of-life) to 4 (most satisfactory quality-of-life) Results are reported as a Scale score which is the average (mean) response to all items in the scale (e.g., add the responses to all questions in a scale together and then divide by the number of items in the scale).
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Peristeen | FIQL Score - Scale 1 Lifestyle, Modified American Society for Colorectal Surgeons Questionnaire | 3.10 score on a scale |
| Standard of Care | FIQL Score - Scale 1 Lifestyle, Modified American Society for Colorectal Surgeons Questionnaire | 2.60 score on a scale |
Secondary
FIQL Score - Scale 2 Coping/Behavior, Modified American Society for Colorectal Surgeons Questionnaire
The FIQL scale was thus interpreted for four scales exploring different aspects of the patient's quality-of-life. the Fecal Incontinence Quality of Life Scale (FIQL) contains 29 questions, across 4 domains, lifestyle (10 questions), Coping/Behavior (9 questions), Depression/Self Perception (7 questions), Embarrassment (3 questions). Items were scored 1 (least satisfactory quality-of-life) to 4 (most satisfactory quality-of-life) Results are reported as a Scale score which is the average (mean) response to all items in the scale (e.g., add the responses to all questions in a scale together and then divide by the number of items in the scale).
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Peristeen | FIQL Score - Scale 2 Coping/Behavior, Modified American Society for Colorectal Surgeons Questionnaire | 2.95 score on a scale |
| Standard of Care | FIQL Score - Scale 2 Coping/Behavior, Modified American Society for Colorectal Surgeons Questionnaire | 2.37 score on a scale |
Secondary
FIQL Score - Scale 3 Depression/Self-perception, Modified American Society for Colorectal Surgeons Questionnaire
The FIQL scale was thus interpreted for four scales exploring different aspects of the patient's quality-of-life. the Fecal Incontinence Quality of Life Scale (FIQL) contains 29 questions, across 4 domains, lifestyle (10 questions), Coping/Behavior (9 questions), Depression/Self Perception (7 questions), Embarrassment (3 questions). Items were scored 1 (least satisfactory quality-of-life) to 4 (most satisfactory quality-of-life) Results are reported as a Scale score which is the average (mean) response to all items in the scale (e.g., add the responses to all questions in a scale together and then divide by the number of items in the scale).
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Peristeen | FIQL Score - Scale 3 Depression/Self-perception, Modified American Society for Colorectal Surgeons Questionnaire | 3.41 score on a scale |
| Standard of Care | FIQL Score - Scale 3 Depression/Self-perception, Modified American Society for Colorectal Surgeons Questionnaire | 3.23 score on a scale |
Secondary
FIQL Score - Scale 4 Embarrassment , Modified American Society For Colorectal Surgeons Questionnaire
The FIQL scale was thus interpreted for four scales exploring different aspects of the patient's quality-of-life. the Fecal Incontinence Quality of Life Scale (FIQL) contains 29 questions, across 4 domains, lifestyle (10 questions), Coping/Behavior (9 questions), Depression/Self Perception (7 questions), Embarrassment (3 questions). Items were scored 1 (least satisfactory quality-of-life) to 4 (most satisfactory quality-of-life) Results are reported as a Scale score which is the average (mean) response to all items in the scale (e.g., add the responses to all questions in a scale together and then divide by the number of items in the scale).
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Peristeen | FIQL Score - Scale 4 Embarrassment , Modified American Society For Colorectal Surgeons Questionnaire | 2.98 score on a scale |
| Standard of Care | FIQL Score - Scale 4 Embarrassment , Modified American Society For Colorectal Surgeons Questionnaire | 2.76 score on a scale |
Secondary
Number of Subjects With Major LARS
Obtained from the LARS score questionnaire on a scale from 0-42 in total score. Subscores are summed to get the total score. With 0 indicating lowest score and 42 highest score. 0-20 indicate No LARS, 21-29 minor LARS, 30-42 Major LARS.
Time frame: 12 weeks
Population: missing data from 1 participant in standard of care
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Peristeen | Number of Subjects With Major LARS | 5 Participants |
| Standard of Care | Number of Subjects With Major LARS | 10 Participants |
Secondary
Satisfaction With Treatment
Satisfaction with current bowel management treatment on a scale from 0 (total dissatisfaction) to 10 (perfect satisfaction) rated on a VAS scale from 0 to 10 cm.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Peristeen | Satisfaction With Treatment | 8.6 score on a scale |
| Standard of Care | Satisfaction With Treatment | 5.9 score on a scale |