Transanal Irrigation for the Management of LARS (TAI-LARS)

February 22, 2023 updated by: Dr. Marylise Boutros, Jewish General Hospital

Transanal Irrigation for the Management of Low Anterior Resection Syndrome (LARS): A Multicenter Crossover Randomized Controlled Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Low anterior resection syndrome (LARS) is a constellation of bowel symptoms which occur following rectal cancer treatment. These symptoms have a well characterized negative impact on a patient's quality of life (QoL) following sphincter sparing surgery. The treatment of LARS is primarily based on the management of symptoms with conservative measures such as dietary changes and fiber supplements, anti-diarrheal medications and pelvic floor physiotherapy. Despite these measures, patients often still experience uncontrolled debilitating symptoms.

Transanal irrigation (TAI) has been described for the management of LARS symptoms that persist after conservative measures have been insufficient. The positive impact of this treatment on LARS and the number of bowel movements experienced by patients has been demonstrated in several, primarily European small studies. This multicenter, assessor-blinded, parallel-group randomized control trial (RCT) will assess the outcomes of an online, nurse-led, North American TAI program for the management of LARS.

This RCT will recruit patients who have undergone a low anterior resection (LAR) with closure of any diverting stoma at least 6 months prior to entry into the trial with a LARS score of >20 at recruitment. Participants will be recruited from five academic hospitals with high volumes of rectal cancer care in Ontario and Quebec, and will be randomized using a computer-generated sequence in balanced blocks, stratified by hospital, to the intervention (TAI) or control (traditional care) arms.

Participants in the intervention arm will be asked to perform TAI every 1-2 days for a six-month period. Teaching on the use of TAI will be given through virtual sessions with an experienced research nurse and supportive material (video and animated text) on a web-based application, eLARS. This is an established online application designed to provide quality health information for patients living with LARS created by our research group. Participants in the intervention arm of this study will be given access to a restricted transanal irrigation section on this application dedicated to this RCT with detailed written instructions and educational videos on the use of TAI. Participants in the control arm of the study will have access to the general eLARS application without the section on the transanal irrigation, and no specific change in their current management routine will be required. The required sample size for this RCT, accounting for attrition, is 99 patients. It is anticipated this patient sample can be accrued from the five interested sites within a year.

The primary outcome of the study will be health-related quality of life (QoL) as measured by the European Organization for Research and Treatment of Cancer core Quality of Life questionnaire (EORTIC-QLQ-C30), with secondary outcomes including evaluation of bowel function by the LARS score, Wexner/Cleveland Clinic Fecal Incontinence Score, and bowel diary and satisfaction with TAI. Participant demographics, disease and treatment characteristics will be obtained via hospital chart review as time of recruitment. The TAI treatment effect on global QoL will be modeled using generalized estimating equations (GEE), accounting for within-subject correlations between responses at different time-points, and possible clustering of responses among participants from the same hospital.

To our knowledge, this will be the first North American trial to assess TAI acceptance and impact on quality of life for patients living with LARS. Furthermore, this will be the largest RCT to date, and the first to use a virtual platform to deliver this service for rectal cancer survivors. This study aims to provide an additional feasible and acceptable treatment option for the management of LARS symptoms refractory to our currently limited treatment options.

Study Type

Interventional

Enrollment (Anticipated)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Recruiting
        • Jewish General Hospital
        • Contact:
      • Montréal, Quebec, Canada
        • Not yet recruiting
        • McGill University Health Centre
        • Contact:
        • Principal Investigator:
          • Sender Liberman

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transanal Irrigation
This group will be instructed on the use of TAI to be perform daily for the three month duration of their treatment arm
Procedure: Transanal Irrigation
Each participant will receive a mailed package of TAI materials, given access to the LARS website, and have two scheduled virtual visits with a trained research nurse to learn how to use TAI once assigned to the intervention arm. These sessions will include one on one session with the nurse for review of the material, discussion of the device and any questions. TAI involves introducing an applicator into the anus for irrigation. An initial volume of 1000 mL will be suggested but can be increased to 1500 mL or reduced to 500 mL as per patient preference and tolerance. Applicators are single-use instruments that can be disposed of into standard waster receptacle after each treatment. The irrigation system is multiple-use and can be used for the duration recommend by the manufacturer manual. Daily irrigation can take anywhere between 20 and 90 minutes depending on individual patient experience.
No Intervention: Tradition care Control arm
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EORTC-QLQ-C30
Time Frame: Monthly for the seven months of the trial
Quality of Life change with treatment. Scale scores are calculated by averaging items within scales and transforming average scores linearly. All of the scales range in score from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning whereas a high score for a symptom scale or item represents a high level of symptomatology or problems. For more details, are available in the EORTC QLQ-C30 Scoring Manual (Fayers et al., 2001)
Monthly for the seven months of the trial

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
LARS Score
Time Frame: Monthly for the seven months of the trial
Bowel function over the course of treatment. Scores range from 0 to 42 0-20: No LARS 21-29: Minor LARS 30-42: Major LARS
Monthly for the seven months of the trial
Satisfaction Survey
Time Frame: Monthly for the seven months of the trial
Satisfaction survey based on LARS Consensus Definition symptoms and consequences
Monthly for the seven months of the trial
Bowel diaries
Time Frame: Will be taken in first and last 2 week periods of each treatment groups
Standardize measure of the number of bowel movement per day
Will be taken in first and last 2 week periods of each treatment groups

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jewish General Hospital

Collaborators

CHU de Quebec-Universite Laval
McGill University Health Centre/Research Institute of the McGill University Health Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2022

Primary Completion (Anticipated)

December 1, 2024

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

August 10, 2021

First Submitted That Met QC Criteria

August 10, 2021

First Posted (Actual)

August 16, 2021

Study Record Updates

Last Update Posted (Estimate)

February 23, 2023

Last Update Submitted That Met QC Criteria

February 22, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MP-05-2022-2925

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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