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

Part of paid clinical trials in Weston, Florida.

Sponsor
Case Comprehensive Cancer Center
Study ID
NCT07219745
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Peristeen Plus Irrigation kit — DEVICE
    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.
  • LARS mobile application — OTHER
    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.

Study Details

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.

Key Dates

Start date
Nov 30, 2025
Status verified
Oct 2025
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Other: Transanal Irrigation (TAI) - intervention arm
    Participants in the TAI-intervention arm will receive TAI (using Peristeen Plus Irrigation kit), training of TAI administration, and access to the LARS app (including TAI module).
  • Other: Continued conservative management - control arm.
    Participants in the control arm will receive conservative management and access to the LARS app (excluding the TAI module). Conservative management includes individualized combinations of dietary modifications, pharmacologic therapies, pelvic floor rehabilitation, and structured follow-up

Primary Outcome Measure

Patient-Reported Outcomes Measurement Information System (PROMIS)-GI Diarrhea at baseline [ Time Frame: Baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Case Comprehensive Cancer Center, Digestive Disease Institute Cleveland Clinic FloridaWestonFlorida33331
Marylise Boutros, MD

Find similar trials in Weston, FL

By condition
Colorectal cancer
By specialty
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By research site
Case Comprehensive Cancer Center, Digestive Disease Institute Cleveland Clinic Florida· Weston, FL

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