Evaluating the Optimal Timing of Trans-Anal Irrigation for Low Anterior Resection Syndrome Post-r… (NCT07696689) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Evaluating the Optimal Timing of Trans-Anal Irrigation for Low Anterior Resection Syndrome Post-rectal Cancer Surgery
250 participantsStarted 2026-09
Plain-language summary
This study aims to evaluate the optimal timing of trans-anal irrigation (TAI) for participants with low anterior resection syndrome (LARS) who have undergone surgery for rectal cancer.
The main question it aims to answer is:
"Can starting TAI within three months of stoma closure reduce the number of daily bowel movements in people who have undergone rectal surgery?" Researchers will compare the outcomes for participants who start TAI within the first three months with those who start after three months, to see if early TAI can reduce the number of daily bowel movements more effectively than starting later.
The study will also determine whether early TAI can improve typical bowel symptoms, enhance quality of life, and increase satisfaction with treatment as much as when it is performed more than three months after stoma closure.
Participants will:
* Undergo a preliminary visit to assess their eligibility to participate
* Undergo training to understand how to use the device correctly
* Perform regular TAI
* Undergo four control visits at 1, 3, 6 and 9 months after the start of treatment.
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:
* Adults aged ≥ 18 years
* Colorectal resection for rectal cancer with a protective ostomy
* Integrity of the colorectal or coloanal anastomosis, as confirmed by each center's standard procedure
* LARS score \> 30 (major LARS)
* Not previously treated with TAI (except for enemas)
* Completion of training on TAI irrigation by trained medical/nursing staff
* Use of only the Peristeen® Plus device for TAI
* Written informed consent
Exclusion Criteria:
* Neurological diseases
* Psychiatric disorders
* Refusal to consent to follow-up
* Current or planned pregnancy
* Known allergy to latex
* Presence of contraindications as outlined in the device's Instructions for Use (IFU), such as ischemic colitis, acute inflammatory bowel disease, or acute diverticulitis.
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
Compare the effectiveness of two treatment regimens, initiated within different time frames following ostomy closure, in reducing the number of bowel movements in 24 hours.
Timeframe: From baseline to 3 months
Trial details
NCT IDNCT07696689
SponsorSimona Ascanelli
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2028-12
Contact for this trial
Simona Ascanelli Ascanelli, MD, Department of Surgery