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

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.

Study Overview

• Status: Recruiting
• Conditions: Low Anterior Resection Syndrome; Rectal Carcinoma
• Intervention / Treatment: Other: Questionnaire Administration; Dietary supplement: Dietary Fiber; Procedure: Enema Administration; Drug: Loperamide Hydrochloride; Procedure: Physical Therapy; Procedure: X-Ray Imaging

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: The Ohio State Comprehensive Cancer Center; Phone Number: 800-293-5066; Email: OSUCCCClinicaltrials@osumc.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • Ohio State University Comprehensive Cancer Center
      • Contact: Alessandra C. Gasior, DO; Phone Number: 614-722-3879; Email: Alessandra.gasior@osumc.edu
      • Principal Investigator: Alessandra C. Gasior, DO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group II (medical management); 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.	Other: Questionnaire Administration; Ancillary studies; Dietary supplement: Dietary Fiber; Receive dietary fiber; Other Names: Fiber; Drug: Loperamide Hydrochloride; Receive loperamide hydrochloride; Other Names: Imodium; Imodium A-D; Procedure: Physical Therapy; Undergo pelvic floor physical therapy; Other Names: Physiatric Procedure; Physical Medicine Procedure; Physical Therapeutics; Physical Therapy Procedure; Physiotherapy; Physiotherapy Procedure
Experimental: Group I (RRE, medical management); 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.	Other: Questionnaire Administration; Ancillary studies; Dietary supplement: Dietary Fiber; Receive dietary fiber; Other Names: Fiber; Procedure: Enema Administration; Undergo RRE; Other Names: Enema; Enema Injection; Drug: Loperamide Hydrochloride; Receive loperamide hydrochloride; Other Names: Imodium; Imodium A-D; Procedure: Physical Therapy; Undergo pelvic floor physical therapy; Other Names: Physiatric Procedure; Physical Medicine Procedure; Physical Therapeutics; Physical Therapy Procedure; Physiotherapy; Physiotherapy Procedure; Procedure: X-Ray Imaging; Undergo abdominal film x-ray; Other Names: Conventional X-Ray; Diagnostic Radiology; Medical Imaging, X-Ray; Radiographic Imaging; Radiography; Static X-Ray; X-Ray; Plain film radiographs; Radiographic imaging procedure (procedure)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility measured by Patient Satisfaction Survey	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.	At 1 year from start of treatment

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Investigators: Principal Investigator: Alessandra C Gasior, DO, Ohio State University Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start (Estimated): August 15, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: May 16, 2024
• First Submitted That Met QC Criteria: May 16, 2024
• First Posted (Actual): May 22, 2024

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Pathological Conditions, Signs and Symptoms; Low Anterior Resection Syndrome; Rectal Neoplasms; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Therapeutics; Drug Therapy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Dietary Carbohydrates; Carbohydrates; Physical Phenomena; Equipment and Supplies; Piperidines; Rehabilitation; Electromagnetic Phenomena; Magnetic Phenomena; Electromagnetic Radiation; Radiation; Radiation, Ionizing; Loperamide; Dietary Fiber; X-Rays; Phantoms, Imaging; Physical Therapy Modalities; Enema
• Other Study ID Numbers: OSU-22312; NCI-2024-03173 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No