Low Anterior Resection Syndrome: Retrograde Enema Program vs Medical Management
Ohio State University Comprehensive Cancer Center
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.
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 Exclusion Criteria: * 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 w…
Interventions
- Dietary SupplementDietary Fiber
Receive dietary fiber
- ProcedureEnema Administration
Undergo RRE
- DrugLoperamide Hydrochloride
Receive loperamide hydrochloride
- ProcedurePhysical Therapy
Undergo pelvic floor physical therapy
- OtherQuestionnaire Administration
Ancillary studies
- ProcedureX-Ray Imaging
Undergo abdominal film x-ray
Location
- Ohio State University Comprehensive Cancer CenterColumbus, Ohio