RecruitingNot ApplicableNCT06424522

A Bowel Management Program (Retrograde Rectal Enema) for the Treatment of Low Anterior Resection Syndrome in Rectal Cancer Patients

Low Anterior Resection Syndrome: Retrograde Enema Program vs Medical Management


Sponsor

Ohio State University Comprehensive Cancer Center

Enrollment

80 participants

Start Date

Aug 15, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This clinical trial studies if a bowel management program with a retrograde rectal enema (RRE) for the treatment of low anterior resection syndrome (LARS) in rectal cancer patients is better than medical management alone. Rectal cancer treatment can include a procedure where part of the rectum with cancer is removed and the remaining part of the rectum is reconnected to the colon, this is called a low anterior resection of the rectum. LARS is a common condition that can develop after undergoing a low anterior resection of the rectum. LARS consists of any change in how the body performs defecation, the discharge of feces from the body, after undergoing a resection procedure. Patients with LARS may experience fecal urgency, incontinence, increased frequency, constipation, feelings of incomplete bowel movement, or bowel emptying difficulties. Patients may experience individual symptoms of LARS or a combination of them. A bowel management program assists patient's with identifying a specific bowel management regimen that works best for managing symptoms of LARS. A RRE consists of inserting a catheter through the anus into the rectum. The RRE is designed to assist fecal emptying. Medical management of LARS can include the use of fiber, loperamide hydrochloride, or pelvic floor physical therapy. Fiber may help relieve constipation, feelings of incomplete bowel movement, or bowel emptying difficulties. Loperamide hydrocholoride may help lessen fecal urgency, incontinence, or increased frequency. Pelvic floor physical therapy may help restore strength in the rectum possibly helping to improve symptoms of LARS. Participating in a bowel management program with a RRE may be more effective in treating LARS than medical management alone.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a bowel management program using retrograde rectal enemas (introducing fluid through the rectum to help regulate bowel movements) for people who experience significant bowel problems after rectal cancer surgery. This condition is called low anterior resection syndrome (LARS). **You may be eligible if...** - You are 18 or older - You have a history of rectal cancer treated with surgery to remove part of the rectum - You have been diagnosed with moderate to severe LARS (ongoing bowel problems after surgery) - Standard medical treatments have not helped your symptoms after 3–6 months **You may NOT be eligible if...** - You have significant bowel narrowing (stricture) requiring surgery - You have had chemotherapy or radiation in the past 6 months - You currently have or have recently had colorectal cancer recurrence - You are pregnant or planning to become pregnant - You have a progressive neurological condition or active sacral infection - You have an active sacral nerve stimulator implant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTDietary Fiber

Receive dietary fiber

PROCEDUREEnema Administration

Undergo RRE

DRUGLoperamide Hydrochloride

Receive loperamide hydrochloride

PROCEDUREPhysical Therapy

Undergo pelvic floor physical therapy

OTHERQuestionnaire Administration

Ancillary studies

PROCEDUREX-Ray Imaging

Undergo abdominal film x-ray


Locations(1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

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NCT06424522


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