Transanal Irrigation for the Management of Early Low Anterior Resection Syndrome (LARS): A Pilot Randomized Controlled Trial
Case Comprehensive Cancer Center
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.
Description
Colorectal cancer is the third most common cancer in the U.S. with 152,810 new cases estimated for 2024. Rectal cancer comprises one-third of all incident cases, with rising incidence among young individuals (1-2% rise/year). With advances in multidisciplinary management, the overall, 5-year survival has improved (68%), and for localized rectal cancers it is excellent (90%), creating a growing rectal cancer survivorship population (currently \>450,000). Traditionally, surgery for rectal cancer required removal of the rectum and the anus, with the creation of a permanent ostomy. However, with r…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. 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, 2. have confirmed anastomotic healing demonstrated by flexible sigmoidoscopy and CT scan with rectally-administered water soluble contrast or gastrograffin enema, 3. are planned for an ileostomy closure operation, and 4. are in the first 12 months post-LAR operation Exclusion Criteria: 1. Inability to comprehend English or Spanish or provide informed consent (Note: after the English…
Interventions
- DevicePeristeen 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.
- OtherLARS 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.
Location
- Case Comprehensive Cancer Center, Digestive Disease Institute Cleveland Clinic FloridaWeston, Florida