Randomized Clinical Trial on Transanal Irrigation

Not Applicable

Completed

Conditions: Low Anterior Resection Syndrome

Interventions: Device: Peristeen cone catheter

Registration Number: NCT04586634

Lead Sponsor: Coloplast A/S

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

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 32

Inclusion Criteria

Be at least 18 years of age and have full legal Capacity
Have given written informed consent
Be mental and physical capable to perform transanal irrigation with cone catheter
Have a LARS score ≥ 30 after rectal resection
Be treated according to individual treatment protocol for conservatory bowel management at participating site
Have proof of complete healing of the anastomosis by endoscopy or radiology before stoma closure
At least 3-months from last surgery in colorectum
Be evaluated to be suitable for transanal Irrigation procedure with a cone catheter by endoscopy, defecography or comparable procedure

Exclusion Criteria

Active/recurrent colorectal cancer
Leaking anastomosis
Known anal or colorectal stenosis
Within 4 weeks of endoscopic polypectomy
Ischaemic colitis
Acute inflammatory bowel disease
Acute diverticulitis
Current or planned pregnancy

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Peristeen	Peristeen cone catheter	Subjects to use newly developed Peristeen cone catherter device

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).
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.
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.
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 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).
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).
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).
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.