NCT05007015Active, not recruiting
Transanal Irrigation for the Management of LARS
Transanal Irrigation for the Management of Low Anterior Resection Syndrome (LARS): A Multicenter Crossover Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 2 Jun 2026
Brief summary (registry, in English)
This study aims to evaluate the impact of Transanal irrigation (TAI) on the quality of life and low anterior resection symptoms (LARS) in Canadian rectal cancer survivors living with minor to major LARS. It proposes to teach TAI through a novel online platform and to provide virtual nursing support for the participants. To our knowledge, this is the first North American based and largest randomized control trial on the use of TAI for patients with LARS. This will also be the first study to teach and support patients through the TAI process using a virtual platform. While TAI has been demonstrated to reduce LARS scores and increased QoL in patients with significant LARS, its feasibility and acceptance for Canadian patients remains uncertain. Furthermore despite the existing studies, the rate of TAI seems to be low in North America. The hypothesis is that TAI, taught and supported through an online portal dedicated to LARS patients, will positively impact QoL and improve LARS symptoms. The results of this trial may allow TAI to become part of the standard armamentarium that clinicians offer patients for LARS management, with the presence of online nursing support and guidance to facilitate this practice.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 66 (estimated)
- First submitted
- 10 Aug 2021
- Start date
- 15 Jan 2022
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- Jewish General Hospital
- Diseases
- Colorectal cancer
- NCT number
- NCT05007015
What you commit to
- Study type: Interventional
- Planned participants: 66
- From 15 Jan 2022 to the primary completion date, 30 Jun 2026
- 8 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.
Other illness
- Active or ongoing treatment for rectal disease.
Other
- Inability to provide informed consent, including insufficient fluency in English or French.
- Inability to access the internet.
- Presence of an ostomy at the time of study enrollment.
- Anastomotic stricture, sinus, or any other ongoing anastomotic complication.
- Current use of TAI under the direction of a clinical team.
Who the study is looking for
- Low anterior resection by a laparoscopic, robotic, transanal total mesorectal excision, or open approach with (or without) creation of a diverting loop ileostomy for the treatment of rectal cancer, advanced adenoma or dysplasia And
- have had their ileostomy closed (if applicable) And
- completed treatment at least 6 months ago (including ileostomy closure) And
- LARS score \> 20 points
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Health Science North Coordinator of this site? Confirm its status | Greater Sudbury | Canada | Unknown status |
| London Health Science Centre Coordinator of this site? Confirm its status | London | Canada | Unknown status |
| Jewish General Hospital Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| McGill University Health Centre Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Centre de Recherche du CHU de Québec - Hôpital Saint-François d'Assise Coordinator of this site? Confirm its status | Québec | Canada | Unknown status |
| University Health Network Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Providence Hospital - St. Paul's Hospital Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
| University of British Columbia - Island Health Colorectal Surgery Coordinator of this site? Confirm its status | Victoria | Canada | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.