Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06424522

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

Led by Ohio State University Comprehensive Cancer Center · Updated on 2026-04-21

80

Participants Needed

1

Research Sites

124 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Diagnosed with moderate to severe low anterior resection syndrome (LARS)
  • History of rectal cancer treated with proctectomy
  • Underwent standard medical management without symptom improvement for 3 to 6 months
Not Eligible

You will not qualify if you...

  • Significant strictures requiring surgical management; minor strictures allowed if catheter can be passed after exam
  • Received chemotherapy or radiation therapy in the last 6 months
  • Current colorectal cancer or recurrent colorectal cancer
  • Had colorectal surgery within the last 3 months
  • Progressive neurological disease
  • Active or recurrent sacral infection
  • Under 18 years old
  • Active sacral nerve stimulator
  • Pregnant or planning pregnancy during treatment
  • Altered mental status or disability affecting ability to self-administer enema
  • Any other reason deemed inappropriate by the research team (e.g., transportation, missed appointments, unreliable communication, vulnerable population)

AI-Screening

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Trial Site Locations

Total: 1 location

1

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States, 43210

Actively Recruiting

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Research Team

T

The Ohio State Comprehensive Cancer Center

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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