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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: OSUCCCClinicaltrials@osumc.edu
• Phone: 800-293-5066

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.