RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Low Anterior Resection Syndrome: Retrograde Enema Program vs Medical Management

Quick Facts

Study Start:2025-06-01
Study Completion:2028-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06424522

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥ 18 years old
  2. * LARS diagnosis
  3. * Patients with history of rectal cancer
  1. * Patients presenting with significant stricture that need a definitive surgical management strategy; patients with minor or clinically negligible strictures can still be candidates. Patients who are able to pass the catheter and the balloon per rectum may be candidates after a digital rectal exam at their initial visit
  2. * Patients with any chemo or radiation therapy in the last 6 months
  3. * Patients who currently have colorectal cancer
  4. * Patients with recurrent colorectal cancer
  5. * Patients who have undergone a colorectal surgical procedure within the last three months
  6. * Patients \< 18 years old
  7. * Active sacral nerve simulator
  8. * Altered mental status or mental disability that would alter ability to self-administer enema
  9. * Any reason the research team believes the subject is not an appropriate candidate for this study (i.e., transportation issues, history of no-show appointments, lack of reliable communications, vulnerable population(s), etc.)

Contacts and Locations

Study Contact

The Ohio State Comprehensive Cancer Center
CONTACT
800-293-5066
OSUCCCClinicaltrials@osumc.edu

Principal Investigator

Alessandra C Gasior, DO
PRINCIPAL_INVESTIGATOR
Ohio State University Comprehensive Cancer Center

Study Locations (Sites)

Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
United States

Collaborators and Investigators

Sponsor: Ohio State University Comprehensive Cancer Center

  • Alessandra C Gasior, DO, PRINCIPAL_INVESTIGATOR, Ohio State University Comprehensive Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-01
Study Completion Date2028-12-31

Study Record Updates

Study Start Date2025-06-01
Study Completion Date2028-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Low Anterior Resection Syndrome
  • Rectal Carcinoma