NCT05245331Active, not recruiting
Transanal Irrigation for Low Anterior Resection Syndrome.
High-volume and Low-volume Water Transanal Irrigation for the Management of Low Anterior Resection Syndrome. A Crossover Randomized Controlled Clinical Trial.
Source: ClinicalTrials.gov · Last updated 16 Sept 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 7 Jan 2022
- Start date
- 4 Aug 2022
- Primary completion date
- 1 Nov 2025
- Lead sponsor
- Hospital Universitari de Bellvitge
- Diseases
- Colorectal cancer
- NCT number
- NCT05245331
What you commit to
- Study type: Interventional
- Planned participants: 20
- From 4 Aug 2022 to the primary completion date, 1 Nov 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Partial or total intersphincteric resection.
- Previous use of transanal irrigation systems for LARS treatment
Other illness
- 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.
- Local or distant rectal cancer recurrence and/or any other active neoplastic disease.
- Any other diseases that may alter results of the study.
Age
- Pregnancy and age \< 18 years
Other
- Side to end mechanical anastomosis or J-pouch colorectal anastomosis
- Functioning sacral neurostimulator carriers.
- Presence of an ostomy.
- Altered cognitive status.
- Refusal to sign the informed consent.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Bellvitge University Hospital Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Universitari de Bellvitge Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.