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

Low Anterior Resection Syndrome: Retrograde Enema Program vs Medical Management

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 1 year
  • Procedures mentioned: X-rays

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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 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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether a bowel care program with a rectal enema works better than medical care alone. The enema uses a tube placed through the anus to help empty the bowel. It is for adults with moderate to severe low anterior resection syndrome (LARS), or bowel problems after rectal cancer surgery.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older.
  • Have moderate to severe LARS.
  • Had rectal cancer treated with surgery to remove part or all of the rectum.
  • Tried standard medical care for 3–6 months without better symptoms.

Who can't join

  • Have major bowel narrowing that needs surgery. Minor narrowing may be allowed if an exam shows the enema tube and balloon can pass.
  • Had chemotherapy or radiation in the past 6 months, or colon or rectal surgery in the past 3 months.
  • Have colon or rectal cancer now, including cancer that has come back.
  • Have a disease of the brain or nerves that is getting worse.
  • Have a current or repeated infection near the base of the spine, or an active device that stimulates nerves in that area.
  • Are under 18, pregnant, or planning to become pregnant during study treatment.
  • Have changes in thinking or a mental disability that affects the ability to give yourself an enema.
  • The research team believes the study is not a good fit, such as because of travel problems, missed visits, trouble staying in contact, or a need for special protections.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.)

Study sites (1)

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