Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Syndrome

Carcinoma

Low Anterior Resection Syndrome

Colonic Diseases

Intestinal Diseases

Gastrointestinal Diseases

Rectal Diseases

Postoperative Complications

Gastrointestinal Agents

All Drugs and Chemicals

Dermatologic Agents

Loperamide

Antidiarrheals

Coal Tar

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.

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.

Dietary Fiber

Enema Administration

Loperamide Hydrochloride

Physical Therapy

Questionnaire Administration

X-Ray Imaging

The Ohio State Comprehensive Cancer Center

Alessandra C. Gasior, DO

Alessandra C Gasior, DO

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.

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

GROUP II: 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.

Upon completion of study intervention all patients are followed up at 1 month, 3 months, and 1 year.

A Bowel Management Program (Retrograde Rectal Enema) for the Treatment of Low Anterior Resection Syndrome in Rectal Cancer Patients

Low Anterior Resection Syndrome: Retrograde Enema Program vs Medical Management

Will be measured using a validated scoring tool for LARS (Memorial Sloan Kettering Cancer Center Bowel Function Instrument Questionnaire \[MSKCC BFI\]). Effect size (Cohen's d \> 0.80) will be computed to ensure the effect of findings. P \< 0.05 is considered significant. Statistical analysis will be conducted using linear or nonlinear mixed modelling as found appropriate by the statistician.

Will be assessed using LARS validated scoring tool. Effect size (Cohen's d \> 0.80) will be computed to ensure the effect of findings. P \< 0.05 is considered significant. Statistical analysis will be conducted using linear or nonlinear mixed modelling as found appropriate by the statistician.

Will be assessed by administering a patient satisfaction survey post treatment. Effect size (Cohen's d \> 0.80) will be computed to ensure the effect of findings. P \< 0.05 is considered significant. Statistical analysis will be conducted using linear or nonlinear mixed modelling as found appropriate by the statistician.

Ohio State University Comprehensive Cancer Center

Principal Investigator

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Bowel Management Program (Retrograde Rectal Enema) for the Treatment of Low Anterior Resection Syndrome in Rectal Cancer Patients	NCT06424522	Low Anterior Re... Rectal Carcinom...	Dietary Fiber Enema Administr... Loperamide Hydr... Physical Therap... Questionnaire A... X-Ray Imaging	18 Years -	Ohio State University Comprehensive Cancer Center
A Bowel Management Program (Retrograde Rectal Enema) for the Treatment of Low Anterior Resection Syndrome in Rectal Cancer Patients	NCT06424522	Low Anterior Re... Rectal Carcinom...	Dietary Fiber Enema Administr... Loperamide Hydr... Physical Therap... Questionnaire A... X-Ray Imaging	18 Years -	Ohio State University Comprehensive Cancer Center
A Bowel Management Program (Retrograde Rectal Enema) for the Treatment of Low Anterior Resection Syndrome in Rectal Cancer Patients	NCT06424522	Low Anterior Re... Rectal Carcinom...	Dietary Fiber Enema Administr... Loperamide Hydr... Physical Therap... Questionnaire A... X-Ray Imaging	18 Years -	Ohio State University Comprehensive Cancer Center

Spots Global Cancer Trial Database for enema administration