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

NCT06424522 | Recruiting DMC

• 2 other identifiers: OSU-22312NCI-2024-03173
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Low Anterior Resection Syndrome; Rectal Carcinoma

Outcome Measures

Primary Outcomes (2)

• Fecal incontinence

  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.

  Up to 1 year from start of treatment

• Effectiveness assessed using LARS validated scoring tool

  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.

  Up to 1 year from start of treatment

Secondary Outcomes (1)

• Feasibility measured by Patient Satisfaction Survey

  At 1 year from start of treatment

Study Arms (2)

Group I (RRE, medical management)

EXPERIMENTAL

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.

Dietary Supplement: Dietary Fiber; Procedure: Enema Administration; Drug: Loperamide Hydrochloride; Procedure: Physical Therapy; Other: Questionnaire Administration; Procedure: X-Ray Imaging

Group II (medical management)

ACTIVE COMPARATOR

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 Supplement: Dietary Fiber; Drug: Loperamide Hydrochloride; Procedure: Physical Therapy; Other: Questionnaire Administration

Interventions

Loperamide Hydrochloride DRUG

Receive loperamide hydrochloride

Also known as: Imodium, Imodium A-D

Group I (RRE, medical management); Group II (medical management)

Questionnaire Administration OTHER

Ancillary studies

Group I (RRE, medical management); Group II (medical management)

Physical Therapy PROCEDURE

Undergo pelvic floor physical therapy

Also known as: Physiatric Procedure, Physical Medicine Procedure, Physical Therapeutics, Physical Therapy Procedure, Physiotherapy, Physiotherapy Procedure

Group I (RRE, medical management); Group II (medical management)

X-Ray Imaging PROCEDURE

Undergo abdominal film x-ray

Also known as: Conventional X-Ray, Diagnostic Radiology, Medical Imaging, X-Ray, Plain film radiographs, Radiographic Imaging, Radiographic imaging procedure (procedure), Radiography, Static X-Ray, X-Ray

Group I (RRE, medical management)

Dietary Fiber DIETARY_SUPPLEMENT

Receive dietary fiber

Also known as: Fiber

Group I (RRE, medical management); Group II (medical management)

Enema Administration PROCEDURE

Undergo RRE

Also known as: Enema, Enema Injection

Group I (RRE, medical management)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

RECRUITING

Related Links

• The Jamesline

MeSH Terms

Conditions

Low Anterior Resection Syndrome; Rectal Neoplasms

Interventions

Dietary Fiber; Enema; Loperamide; Physical Therapy Modalities; X-Rays; Phantoms, Imaging

Condition Hierarchy (Ancestors)

Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Rectal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Dietary Carbohydrates; Carbohydrates; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Drug Therapy; Therapeutics; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Rehabilitation; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing; Equipment and Supplies

Study Officials

• Alessandra C Gasior, DO

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

The Ohio State Comprehensive Cancer Center

CONTACT

800-293-5066; OSUCCCClinicaltrials@osumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: May 22, 2024
• Study Start (Estimated): August 15, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)