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

RecruitingNAAges 18 Years - anyAllOhio State University Comprehensive Cancer Center
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In plain words

What the trial is, and whether it could suit you

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 L

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age โ‰ฅ 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.)
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What it tests

  • Dietary Fiber
  • Enema Administration
  • Loperamide Hydrochloride
  • Physical Therapy
  • Questionnaire Administration
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Where

1 site
Ohio State University Comprehensive Cancer Center
Columbus, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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