Actively Recruiting
Low Anterior Resection Syndrome: Retrograde Enema Program versus Medical Management for 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 management—including fiber, loperamide hydrochloride, and pelvic floor physical therapy—plus 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 year
Participants are assigned to one of two treatment groups for 1 year: Group I uses a bowel management program combining medical management with a retrograde rectal enema system to self-administer enemas; Group II receives medical management alone including fiber, loperamide hydrochloride, and pelvic floor physical therapy. Participants may undergo abdominal x-rays during treatment.
Visits as needed for medical management and abdominal x-rays during treatment
Duration - 1 year
After completing treatment, participants are followed up at 1 month, 3 months, and 1 year to assess outcomes and satisfaction.
3 visits (in-person) at 1 month, 3 months, and 1 year post-treatment
Trial Site Locations
Total: 1 location
1
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
T
The Ohio State Comprehensive Cancer Center
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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