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

NCT07219745 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: CASE3225
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Colorectal Cancer; Low Anterior Resection Syndrome

Keywords

Transanal irrigation; Peristeen Transanal Irrigation System; Low Anterior Resection Syndrome; LARS

Outcome Measures

Primary Outcomes (9)

• Patient-Reported Outcomes Measurement Information System (PROMIS)-GI Diarrhea at baseline

  PROMIS\_GI Diarrhea with domains covering Frequency, urgency, burden. T-score (mean = 50, SD = 10); higher scores = worse diarrhea

  Baseline

• Patient-Reported Outcomes Measurement Information System (PROMIS)-GI Diarrhea at 1 month

  PROMIS\_GI Diarrhea with domains covering Frequency, urgency, burden. T-score (mean = 50, SD = 10); higher scores = worse diarrhea

  1 month post randomization

• Patient-Reported Outcomes Measurement Information System (PROMIS)-GI Diarrhea at 2 months

  PROMIS\_GI Diarrhea with domains covering Frequency, urgency, burden. T-score (mean = 50, SD = 10); higher scores = worse diarrhea

  2 months post randomization

• Patient-Reported Outcomes Measurement Information System (PROMIS)-GI Diarrhea at 3 months

  PROMIS\_GI Diarrhea with domains covering Frequency, urgency, burden. T-score (mean = 50, SD = 10); higher scores = worse diarrhea

  3 months post randomization

• PROMIS-GI Fecal Incontinence at baseline

  PROMIS\_GI Fecal Incontinence with domains covering Leakage, control, impact . T-score (mean = 50, SD = 10); higher scores = worse incontinence

  Baseline

• PROMIS-GI Fecal Incontinence at 1 month

  PROMIS\_GI Fecal Incontinence with domains covering Leakage, control, impact . T-score (mean = 50, SD = 10); higher scores = worse incontinence

  1 month post randomization

• PROMIS-GI Fecal Incontinence at 2 months

  PROMIS\_GI Fecal Incontinence with domains covering Leakage, control, impact . T-score (mean = 50, SD = 10); higher scores = worse incontinence

  2 months post randomization

• PROMIS-GI Fecal Incontinence at 3 months

  PROMIS\_GI Fecal Incontinence with domains covering Leakage, control, impact . T-score (mean = 50, SD = 10); higher scores = worse incontinence

  3 months post randomization

• Average monthly randomization rate

  Participants who report a LARS Score of ≥20-the threshold for moderate-to-severe LARS-will meet criteria for randomization. Score range: 0-42 (higher scores = more severe LARS; 0-20 = no LARS, 21-29 = minor, 30-42 = major)

  3 months post ileostomy

Secondary Outcomes (31)

• PROMIS Physical Function at baseline

  Baseline

• PROMIS Physical Function at 1 month

  1 month post randomization

• PROMIS Physical Function at 2 months

  2 months post randomization

• PROMIS Physical Function at 3 months

  3 months post randomization

• PROMIS Ability to Participate in Social Roles and Activities at baseline

  Baseline

Study Arms (2)

Transanal Irrigation (TAI) - intervention arm

OTHER

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).

Device: Peristeen Plus Irrigation kit; Other: LARS mobile application

Continued conservative management - control arm.

OTHER

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

Other: LARS mobile application

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.

Transanal Irrigation (TAI) - intervention arm

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.

Continued conservative management - control arm.; Transanal Irrigation (TAI) - intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (≥18 years-old) patients who underwent a LAR for any indication via open, laparoscopic, robotic, or transanal total mesorectal excision, with creation of a diverting loop ileostomy,
• have confirmed anastomotic healing demonstrated by flexible sigmoidoscopy and CT scan with rectally-administered water soluble contrast or gastrograffin enema,
• are planned for an ileostomy closure operation, and
• are in the first 12 months post-LAR operation

You may not qualify if:

• Inability to comprehend English or Spanish or provide informed consent (Note: after the English documents are approved, the study team plans to obtain a Spanish consent and study documents),
• ongoing chemotherapy or radiotherapy, and
• ongoing anastomotic complication.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Case Comprehensive Cancer Center, Digestive Disease Institute Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Low Anterior Resection Syndrome

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Marylise Boutros, MD

CONTACT

954-659-5278; CORSFLresearch@ccf.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2025
• First Posted: October 22, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: October 22, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Time Frame: The data will be kept in a de-identified manner for 10 years following study completion. The data will then be reported anonymously and kept indefinitely.

Locations

US (1)