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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up monthly for the seven months of the trial
Awards & highlights

TAI-LARS Trial Summary

This trial will test whether a treatment called Transanal irrigation (TAI) can improve quality of life and reduce symptoms in Canadian rectal cancer survivors living with minor to major LARS. TAI involves flushing the rectum with water to clean it out, and has been shown to be effective in other studies. However, it is not known whether TAI is feasible or acceptable for Canadian patients, or whether online nursing support can help patients through the process.

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.Check my eligibility
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.See study design
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.

TAI-LARS Trial Eligibility Criteria

Inclusion Criteria

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

TAI-LARS Trial 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

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

TAI-LARS 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.

Find a Location

Who is running the clinical trial?

Jewish General HospitalLead Sponsor
137 Previous Clinical Trials
271,980 Total Patients Enrolled
McGill University Health Centre/Research Institute of the McGill University Health CentreOTHER
441 Previous Clinical Trials
159,004 Total Patients Enrolled
CHU de Quebec-Universite LavalOTHER
166 Previous Clinical Trials
106,928 Total Patients Enrolled

Media Library

Transanal Irrigation Clinical Trial Eligibility Overview. Trial Name: NCT05007015 — N/A
Anterior Resection Syndrome Research Study Groups: Tradition care Control arm, Transanal Irrigation
Anterior Resection Syndrome 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are being registered for this experiment?

"Affirmative, the clinical trial is in progress. The initial posting of this study was on January 15th 2022 and it has been recently updated at the start of 2021. 64 participants are needed between two different medical facilities."

Answered by AI

Is there any capacity left to accommodate more participants in this study?

"Affirmative, the information on clinicaltrials.gov confirms that this medical trial is currently recruiting participants. This study was initially posted on January 15th 2022 and has been modified as recently as January 18th 2022. The research team requires 64 volunteers to be recruited between two sites."

Answered by AI
Recent research and studies
~16 spots leftby Dec 2024