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

Last updated: June 20, 2025
Sponsor: Ohio State University Comprehensive Cancer Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Colon Cancer; Rectal Cancer

Treatment

Questionnaire Administration

Physical Therapy

Dietary Fiber

Clinical Study ID

NCT06424522
OSU-22312
NCI-2024-03173
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Age ≥ 18 years old

  • LARS diagnosis

  • Patients with history of rectal cancer

Exclusion

Exclusion Criteria:

  • Patients presenting with significant stricture that need a definitive surgicalmanagement strategy; patients with minor or clinically negligible strictures canstill be candidates. Patients who are able to pass the catheter and the balloon perrectum may be candidates after a digital rectal exam at their initial visit

  • Patients with any chemo or radiation therapy in the last 6 months

  • Patients who currently have colorectal cancer

  • Patients with recurrent colorectal cancer

  • Patients who have undergone a colorectal surgical procedure within the last threemonths

  • Patients < 18 years old

  • Active sacral nerve simulator

  • Altered mental status or mental disability that would alter ability toself-administer enema

  • Any reason the research team believes the subject is not an appropriate candidatefor this study (i.e., transportation issues, history of no-show appointments, lackof reliable communications, vulnerable population(s), etc.)

Study Design

Total Participants: 80
Treatment Group(s): 6
Primary Treatment: Questionnaire Administration
Phase:
Study Start date:
September 01, 2025
Estimated Completion Date:
December 31, 2028

Study Description

PRIMARY OBJECTIVE:

I. To compare two approved pathways for treatment of low anterior resection syndrome (LARS) - a retrograde enema program versus a medical management pathway.

SECONDARY OBJECTIVE:

I. The determination of feasibility to complete this treatment pathway.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients undergo a bowel management program comprising a medical management pathway (fiber, loperamide hydrochloride, pelvic floor physical therapy) in combination with RRE treatment for 1 year. Patients use the RRE system to self administer an individualized enema regimen via the rectum. Patients may undergo abdominal film x-rays throughout the trial.

GROUP II: Patients receive medical management comprising fiber, loperamide hydrochloride, and pelvic floor therapy for 1 year. If medical management fails, patients may then be referred for surgery with sacral nerve stimulator placement.

Upon completion of study intervention all patients are followed up at 1 month, 3 months, and 1 year.

Connect with a study center

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio 43210
    United States

    Active - Recruiting

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