Actively Recruiting
Comparing Retrograde Enema Program and Medical Management for Treating 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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating treatments for low anterior resection syndrome LARS, a condition affecting bowel function after part of the rectum is surgically removed in rectal cancer patients. LARS can cause symptoms like urgency, incontinence, frequent bowel movements, constipation, and incomplete emptying. This trial compares a bowel management program using a retrograde rectal enema RRE with standard medical management to determine which approach better manages LARS symptoms. Participants are randomly assigned to one of two groups. One group receives a combination of medical managementincluding fiber, loperamide hydrochloride, and pelvic floor physical therapyplus a self-administered RRE enema regimen for one year. The other group receives medical management alone for one year and may be referred for surgery if symptoms persist. Abdominal x-rays may be performed during the trial for participants using the RRE. Throughout the study, participants will be assessed using a validated LARS scoring tool and surveys to measure fecal incontinence and patient satisfaction up to one year after treatment starts. Follow-up visits occur at one month, three months, and one year after completing the intervention. The trial aims to evaluate effectiveness, feasibility, and symptom control of the treatments over this period.
CONDITIONS
Brief Title
A Bowel Management Program (Retrograde Rectal Enema) for the Treatment of Low Anterior Resection Syndrome in Rectal Cancer Patients
Who Can Participate
Eligibility Criteria
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
- Has undergone standard medical management without symptom improvement for 3 to 6 months
You will not qualify if you...
- Significant rectal strictures requiring surgery; minor strictures allowed if catheter can pass after exam
- Chemotherapy or radiation therapy within the last 6 months
- Current colorectal cancer diagnosis
- Recurrent colorectal cancer
- Colorectal surgery within the last 3 months
- Progressive neurological disease
- Active or recurrent sacral infection
- Under 18 years old
- Active sacral nerve stimulator device
- Pregnant or planning pregnancy during treatment
- Altered mental status or disability affecting enema self-administration
- Any factor making the participant unsuitable, such as transportation issues or unreliable communication
Research Team
T
The Ohio State Comprehensive Cancer Center
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