Transanal Irrigation for Low Anterior Resection Syndrome.
Spain20 participantsStarted 2022-08-04
Plain-language summary
The aim of this study is to investigate whether the high-volume transanal irrigation (TAI) performed by the Peristeen Plus® system is superior to the low-volume TAI performed by standard 250ml water enema for the treatment of Low Anterior Resection Syndrome (LARS).
Who can participate
Age range
18 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:
* Personal history of LAR or ultra-LAR with total mesorectal excision (TME) and sphincter preservation with stapled or manual end to end anastomosis for primary rectal cancer.
* Major LARS (score 30-42).
* At least 1 year follow-up after LAR or ultra-LAR or temporary stoma closure.
* Anastomotic integrity demonstrated by endoscopic, radiologic or clinical examination.
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) between 0-2.
* Age≥ 18 years
Exclusion Criteria:
* Side to end mechanical anastomosis or J-pouch colorectal anastomosis
* Partial or total intersphincteric resection.
* Personal history of anastomotic dehiscence, chronic pelvic sepsis, anastomotic sinus, anastomotic stricture or other any other anastomotic complications.
* Persona history of other colorectal, proctologic or pelvis surgery or disease.
* Personal history of bariatric surgery.
* Functioning sacral neurostimulator carriers.
* Previous use of transanal irrigation systems for LARS treatment
* Presence of an ostomy.
* Local or distant rectal cancer recurrence and/or any other active neoplastic disease.
* Altered cognitive status.
* Pregnancy and age \< 18 years
* Any other diseases that may alter results of the study.
* Refusal to sign the informed consent.
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: day 1st, 30th, 60th, 75th, 105th, and 135th.