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

Launched by OHIO STATE UNIVERSITY COMPREHENSIVE CANCER CENTER · May 16, 2024

Keywords

ClinConnect Summary

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 en...

Gender

ALL

Eligibility criteria

• 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.)

Trial Officials