Bowel Management Program for Colorectal Cancer
Trial Summary
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop your current medications. It might be best to discuss this with the research team or your doctor.
Is the retrograde rectal enema safe for humans?
Research on retrograde colonic irrigation, which is similar to retrograde rectal enema, has been conducted for conditions like fecal incontinence after rectal surgery. While specific safety data for colorectal cancer is not detailed, the procedure is generally used in medical settings, suggesting it is considered safe for human use in certain conditions.12345
How does the treatment Retrograde Rectal Enema differ from other treatments for colorectal cancer?
The Retrograde Rectal Enema is unique because it involves administering a solution directly into the rectum to manage bowel function, which is different from standard treatments like surgery or chemotherapy that target cancer cells directly. This method may help improve bowel management specifically, which is not typically the focus of other colorectal cancer treatments.678910
What is the purpose of this trial?
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.
Research Team
Alessandra C Gasior, DO
Principal Investigator
Ohio State University Comprehensive Cancer Center
Eligibility Criteria
This trial is for rectal cancer patients who have undergone a low anterior resection and are now experiencing LARS, which includes symptoms like fecal urgency, incontinence, constipation, or difficulty emptying the bowel. The study seeks individuals struggling with these post-surgery changes to their bowel habits.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo a bowel management program with either RRE and medical management or medical management alone for 1 year
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Retrograde Rectal Enema
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ohio State University Comprehensive Cancer Center
Lead Sponsor