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

NANot yet recruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

November 30, 2025

Primary Completion Date

November 30, 2026

Study Completion Date

November 30, 2026

Conditions
Colorectal CancerLow Anterior Resection Syndrome
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."

Trial Locations (1)

33331

Case Comprehensive Cancer Center, Digestive Disease Institute Cleveland Clinic Florida, Weston

All Listed Sponsors
lead

Case Comprehensive Cancer Center

OTHER

NCT07219745 - Transanal Irrigation for the Management of Early Low Anterior Resection Syndrome (LARS) | Biotech Hunter | Biotech Hunter