MedTrace Logo

Transanal Irrigation for the Management of Early Low Anterior Resection Syndrome (LARS)

NCT07219745 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-10-22

No results posted yet for this study

Summary

Transanal irrigation (TAI) has shown to improve fecal incontinence and increase quality of life in patients with low anterior resection syndrome (LARS). This trial is a small study being conducted to determine whether a larger trial is feasible. Investigators are also doing this research to see if TAI impacts quality of life and improves bowel function within the early post-operative period (1-12 months).

This treatment is designed for participants to have more control over their bowel movements and reduce the dependency on immediate access to the toilet.

Conditions

Interventions

DEVICE

Peristeen Plus Irrigation kit

Transanal irrigation TAI is performed by inserting an applicator into the anal canal, inflating a balloon to occlude passage of stool and then installing 500-1000 mL of tap water via an irrigation system to fill the rectum and distal colon, followed by evacuation of bowel contents. Participants in the TAI-intervention arm will receive in-person training to learn how to use TAI and will also be given weekly virtual or in-person follow-up appointments for the first 4 weeks to troubleshoot any issues with TAI. Participants will do TAI once per day for 3 months. Each session of TAI takes about 20-60 minutes, depending on the individual's experience and bowel response.

OTHER

LARS mobile application

Both arms will receive access to the LARS mobile application, which is a digital self-management tool. The app provides interactive educational content, personalized bowel function diaries, guided video tutorials, and peer testimonials, all designed to enhance engagement, promote self-efficacy, and support long-term self-management. The TAI-intervention arm will also receive access to a TAI Module on the LARS app that will offer comprehensive educational resources, including step-by-step guidance, animations, photographs, and participant videos to reinforce safe and confident use of the TAI system.

Sponsors & Collaborators

  • Case Comprehensive Cancer Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-30
Primary Completion
2026-11-30
Completion
2026-11-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07219745 on ClinicalTrials.gov