Randomized Clinical Trial on Transanal Irrigation

Study Overview
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Brief Summary
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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 termination

Official Title
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Randomized Clinical Trial Assessing the Effect of Transanal Irrigation With Cone Catheter Versus Conservative Bowel Management on Symptoms of Low Anterior Resection Syndrome After Rectal Resection

Conditions
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Low Anterior Resection Syndrome

Intervention / Treatment
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* Device: Peristeen cone catheter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Peristeen<br>Subjects to use newly developed Peristeen cone catherter device | Device: Peristeen cone catheter<br>* 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.<br>|
| No Intervention: Standard of care<br>subjects continue with their standard of care treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LARS score | obtained from the LARS score questionnaire | measured pr subject at study termination after 12 weeks |