NCT06424522Recruiting
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
Source: ClinicalTrials.gov · Last updated 6 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 16 May 2024
- Start date
- 15 Feb 2027
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Ohio State University Comprehensive Cancer Center
- Diseases
- Colorectal cancer
- NCT number
- NCT06424522
What you commit to
- Study type: Interventional
- Planned participants: 80
- From 15 Feb 2027 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Patients with any chemo or radiation therapy in the last 6 months
- Patients who have undergone a colorectal surgical procedure within the last three months
Other illness
- Patients who currently have colorectal cancer
- Patients with recurrent colorectal cancer
- Patients with progressive neurological disease
- Patients with active or recurrent sacral infection
- 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.)
Age
- Patients \< 18 years old
Other
- Active sacral nerve simulator
- Pregnant or planning to become pregnant during the treatment portion of the study
- Altered mental status or mental disability that would alter ability to self-administer enema
Who the study is looking for
- Age ≥ 18 years old
- Moderate to Severe LARS diagnosis
- Patients with history of rectal cancer that was treated with proctectomy
- Has undergone standard medical management without improvement of symptoms for 3-6 months
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ohio State University Comprehensive Cancer Center Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.