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

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.

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.)