What side effects are associated with this type of intervention?

Transanal Irrigation (TAI) is a common treatment for managing symptoms of Anterior Resection Syndrome (LARS). Known side effects of TAI include abdominal pain, bloating, and rectal discomfort. Some patients may also experience issues with the irrigation process itself, such as difficulty in performing the procedure or discomfort during the irrigation. Despite these side effects, TAI has been shown to improve overall bowel function and quality of life in many patients.

What prior FDA approvals exist?

There are no specific FDA-approved drugs or treatments explicitly for Anterior Resection Syndrome (ARS) that function similarly to Transanal Irrigation (TAI). TAI, which mechanically flushes the rectum to manage bowel function and reduce LARS symptoms, is a non-pharmacological intervention and is not typically subject to FDA drug approval processes. However, TAI is recognized in clinical practice for its effectiveness in managing bowel dysfunction post-surgery.

What other types of research exist?

Promising novel alternatives to Transanal Irrigation (TAI) for managing Anterior Resection Syndrome (LARS) symptoms include: 1) Sacral Nerve Stimulation (SNS), which modulates nerve signals to improve bowel control; 2) Biofeedback therapy, which helps patients improve bowel function through guided exercises and muscle training; 3) Pharmacological treatments such as new formulations of anti-diarrheal or motility-modifying agents; and 4) Dietary modifications and probiotics aimed at improving gut health and function. These alternatives have shown potential in improving bowel function and quality of life in patients with LARS.

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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)

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

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not currently receiving any treatments.

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I have complications from a previous surgical connection between two parts of my body.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ monthly for the seven months of the trial

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.

0 / 5Eligibility criteria met

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.