A Bowel Management Program (Retrograde Rectal Enema) for the Treatment of Low Anterior Resection Syndrome in Rectal Cancer Patients
Recruiting · NCT06424522 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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 with any chemo or radiation therapy in the last 6 months
- Patients who currently have colorectal cancer
- Patients with recurrent colorectal cancer
- Patients who have undergone a colorectal surgical procedure within the last three months
- Patients with progressive neurological disease
- Patients with active or recurrent sacral infection
- Patients \< 18 years old
- 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
- 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.)
Where it is running
1 location listed across 1 US state.
- Ohio State University Comprehensive Cancer Center - Columbus, Ohio, United States