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
Who can participate
Age range
18 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
LARS Score
Timeframe: Total score measured per subject at study completion after 12 weeks