Bowel Management Program for Colorectal Cancer

Overseen by Alessandra C Gasior, DO

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: Ohio State University Comprehensive Cancer Center

No Placebo Group

Trial Summary

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

I am 18 years old or older.

I have been diagnosed with LARS.

I have a history of rectal cancer.

Exclusion Criteria

My colorectal cancer has come back.

I am under 18 years old.

Active sacral nerve simulator

Treatment Details

Interventions

• Retrograde Rectal Enema (Behavioural Intervention)

Trial Overview The study is testing if a bowel management program using retrograde rectal enemas (RRE) can better manage LARS symptoms compared to standard medical treatments alone. This involves inserting a catheter into the rectum to help with fecal emptying alongside dietary adjustments, medication like loperamide hydrochloride, and physical therapy.

Participant Groups

Group I: Group I (RRE, medical management) Experimental Treatment 6 Interventions

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 regimen via the rectum. Patients may undergo abdominal film x-rays throughout the trial.

Group II: Group II (medical management) Active Control 4 Interventions

Patients receive medical management comprising fiber, loperamide hydrochloride, and pelvic floor therapy for 1 year. If medical management fails, patients may then be referred for surgery with sacral nerve stimulator placement.

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

Dr. David Cohn

Ohio State University Comprehensive Cancer Center

Interim Chief Executive Officer since 2022

MD, MBA

Dr. David Cohn

Ohio State University Comprehensive Cancer Center

Chief Medical Officer since 2018

MD