Using Transanal Irrigation to Help Rectal Cancer Survivors with Bowel Symptoms
Transanal Irrigation for the Management of Low Anterior Resection Syndrome (LARS): a Multicenter Crossover Randomized Controlled Trial
This study is testing if teaching rectal cancer survivors how to use Transanal irrigation can help improve their bowel symptoms and quality of life after surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Jewish General Hospital Academic / other |
| Locations | 2 sites (Montreal, Quebec and 1 other locations) |
| Trial ID | NCT05007015 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of Transanal irrigation (TAI) in improving the quality of life and alleviating symptoms of Low Anterior Resection Syndrome (LARS) in rectal cancer survivors. Participants will be taught how to perform TAI through a novel online platform, with virtual nursing support provided throughout the process. This multicenter, randomized control trial will recruit patients from five academic hospitals in Ontario and Quebec, focusing on those who have undergone low anterior resection surgery and experience significant LARS symptoms. The study aims to determine the feasibility and acceptance of TAI among Canadian patients, as previous studies have shown positive outcomes in Europe.
Who should consider this trial
Good fit: Ideal candidates are rectal cancer survivors who have undergone low anterior resection surgery and have a LARS score greater than 20.
Not a fit: Patients with an ostomy, ongoing treatment, or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life for rectal cancer survivors suffering from LARS.
How similar studies have performed: While TAI has shown positive results in European studies, this is the first large-scale randomized control trial in North America, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Inability to provide informed consent, including fluency in English or French language * unable to access the internet, * presence of an ostomy, * no active or ongoing treatment * anastomotic stricture, sinus or any other ongoing anastomotic complications.
Where this trial is running
Montreal, Quebec and 1 other locations
- Jewish General Hospital — Montreal, Quebec, Canada (Recruiting)
- McGill University Health Centre — Montréal, Quebec, Canada (Not_yet_recruiting)
Study contacts
- Study coordinator: Sarah Sabboobeh
- Email: sarah.sabboobeh@ladydavis.ca
- Phone: 514-320-8222
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.