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

Official title

Low Anterior Resection Syndrome: Retrograde Enema Program vs Medical Management

Overview

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.

Detailed 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.

Interventions

• 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

Primary outcome measures

• Fecal incontinence [Time frame: Up to 1 year from start of treatment]
• Effectiveness assessed using LARS validated scoring tool [Time frame: Up to 1 year from start of treatment]

Secondary outcome measures (1)

• Feasibility measured by Patient Satisfaction Survey [Time frame: At 1 year from start of treatment]

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.)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 1 center

• Ohio State University Comprehensive Cancer Center — Columbus

Identifiers

NCT: NCT06424522 · OSU-22312 · NCI-2024-03173

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗