Bowel management program for treating low anterior resection syndrome in rectal cancer patients

Low Anterior Resection Syndrome: Retrograde Enema Program vs Medical Management

This study is testing a bowel management program using special enemas to see if it helps people with low anterior resection syndrome after rectal cancer surgery feel better compared to standard treatment.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Ohio State University Comprehensive Cancer Center (other)
• Drugs / interventions: radiation
• Locations: 1 site (Columbus, Ohio)
• Trial ID: NCT06424522 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of a bowel management program using retrograde rectal enemas (RRE) compared to standard medical management for patients suffering from low anterior resection syndrome (LARS) following rectal cancer surgery. Participants will be randomized into two groups: one receiving the bowel management program with RRE and the other receiving only medical management. The study aims to assess the feasibility and outcomes of these treatment pathways over a one-year period, with follow-up assessments at one month, three months, and one year post-intervention.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have been diagnosed with LARS following rectal cancer treatment.

Not a fit: Patients with significant rectal strictures requiring surgical intervention or those currently undergoing treatment for colorectal cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this program could significantly improve bowel function and quality of life for patients suffering from LARS.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in managing bowel dysfunction, suggesting potential for success.

Eligibility criteria

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.)

Where this trial is running

Columbus, Ohio

• Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States (RECRUITING)

Study contacts

• Principal investigator: Alessandra C Gasior, DO — Ohio State University Comprehensive Cancer Center
• Study coordinator: The Ohio State Comprehensive Cancer Center

Conditions: Low Anterior Resection Syndrome, Rectal Carcinoma