← Back to Search

Transanal Irrigation for LARS (TAI-LARS Trial)

N/A
Recruiting
Research Sponsored by Jewish General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Have had their ileostomy closed (if applicable)
Must not have
No active or ongoing treatment
Presence of an anastomotic stricture, sinus, or any other ongoing anastomotic complications.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up monthly for the seven months of the trial
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing if using water to flush out the bowel can help Canadian rectal cancer survivors with severe bowel symptoms. The treatment will be taught and supported online by nurses. The goal is to see if this method improves their quality of life and reduces symptoms. This method has shown promise in clinical experience but lacks extensive scientific evidence.

Who is the study for?
This trial is for Canadian rectal cancer survivors who have completed treatment at least 6 months ago, including ileostomy closure if applicable. They should be experiencing low anterior resection symptoms (LARS) with a score over 20 points and must be able to give informed consent in English or French and access the internet.
What is being tested?
The study tests Transanal Irrigation (TAI) taught via an online platform with virtual nursing support to improve quality of life and alleviate LARS in patients. It's a randomized control trial aiming to establish TAI as a standard option for managing LARS symptoms in North America.
What are the potential side effects?
While specific side effects are not detailed, TAI generally may cause discomfort, bowel irritation, or infection risk due to improper use. Virtual nursing aims to minimize these by guiding proper technique.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I had surgery for rectal cancer or advanced adenoma using a specific technique.
Select...
My ileostomy has been closed.
Select...
I finished my treatment, including any surgery to close an ileostomy, over 6 months ago.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am not currently receiving any treatments.
Select...
I have complications from a previous surgical connection between two parts of my body.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~monthly for the seven months of the trial
This trial's timeline: 3 weeks for screening, Varies for treatment, and monthly for the seven months of the trial for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
EORTC-QLQ-C30
Secondary study objectives
Bowel diaries
LARS Score
Satisfaction Survey

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Transanal IrrigationExperimental Treatment1 Intervention
This group will be instructed on the use of TAI to be perform daily for the three month duration of their treatment arm
Group II: Tradition care Control armActive Control1 Intervention
This group tradition care group will have no modification to the care they have received prior to commencing the study. The patients in this group will use the usual dietary modifications and medications prescribed by the treating team to manage their LARS. No changes will be made to the treatment regime prescribed by their surgeon.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Transanal Irrigation (TAI) works by mechanically flushing the rectum with water, which helps to manage bowel function and reduce symptoms of Low Anterior Resection Syndrome (LARS). This process can help regulate bowel movements, reduce incontinence, and improve the overall quality of life for patients suffering from LARS. By providing a controlled and predictable method of bowel evacuation, TAI can significantly alleviate the discomfort and social embarrassment associated with LARS, making it a valuable treatment option for these patients.

Find a Location

Who is running the clinical trial?

Jewish General HospitalLead Sponsor
142 Previous Clinical Trials
279,585 Total Patients Enrolled
McGill University Health Centre/Research Institute of the McGill University Health CentreOTHER
470 Previous Clinical Trials
166,878 Total Patients Enrolled
CHU de Quebec-Universite LavalOTHER
172 Previous Clinical Trials
109,609 Total Patients Enrolled

Media Library

Transanal Irrigation Clinical Trial Eligibility Overview. Trial Name: NCT05007015 — N/A
Colorectal Cancer Research Study Groups: Tradition care Control arm, Transanal Irrigation
Colorectal Cancer Clinical Trial 2023: Transanal Irrigation Highlights & Side Effects. Trial Name: NCT05007015 — N/A
Transanal Irrigation 2023 Treatment Timeline for Medical Study. Trial Name: NCT05007015 — N/A
~17 spots leftby Dec 2025