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

Low Anterior Resection Syndrome Clinical Trial

Official title:

Low Anterior Resection Syndrome: Retrograde Enema Program vs Medical Management

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06424522
• Other study ID #: OSU-22312
• Secondary ID: NCI-2024-03173
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: October 31, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: May 2024
• Source: Ohio State University Comprehensive Cancer Center
• Contact: The Ohio State Comprehensive Cancer Center
• Phone: 800-293-5066
• Email: OSUCCCClinicaltrials[@]osumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years old

• LARS diagnosis

• Patients with history of rectal cancer

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 < 18 years old

• Active sacral nerve simulator

• 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.)

Related Conditions & MeSH terms

• Low Anterior Resection Syndrome
• Rectal Carcinoma
• Syndrome

Intervention

Dietary Supplement:
• Dietary Fiber
Receive dietary fiber

Procedure:
• Enema Administration
Undergo RRE

Drug:
• Loperamide Hydrochloride
Receive loperamide hydrochloride

Procedure:
• Physical Therapy
Undergo pelvic floor physical therapy

Other:
• Questionnaire Administration
Ancillary studies

Procedure:
• X-Ray Imaging
Undergo abdominal film x-ray

Locations

Country	Name	City	State
United States	Ohio State University Comprehensive Cancer Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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

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