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Use of Post Operative Loperamide in Colorectal Patients After Diverting Ileostomies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02263365
Recruitment Status : Terminated (Unable to meet study requirements)
First Posted : October 13, 2014
Results First Posted : December 20, 2017
Last Update Posted : December 20, 2017
Information provided by (Responsible Party):
Phillip Fleshner MD, Cedars-Sinai Medical Center

Brief Summary:

Dehydration post creation of a diverting ileostomy is a common and debilitating problem faced by patients undergoing ileal-anal pouch anastomoses for both inflammatory bowel disease and familial adenomatous polyposis (FAP) syndrome. Those patients with low rectal cancers or other polyposis syndromes e.g. HNPCC hereditary non polyposis colorectal cancers, may potentially have a delay in the adjuvant therapy when faced with this complication.

Studies performed in this groups of patients report a readmission rate of 17-21% for dehydration.

Loperamide has been shown to significantly decrease the daily volume of weight of stool in these patients.

The purpose of this study is to establish whether loperamide given at 4mg three times daily for 14 days from day of discharge empirically decreases 30 days readmission rate for dehydration.

The investigators hypothesize that there will be a 15% decrease from 25% to 10% in the readmission rates, that severity of dehydration will be decreased.

Condition or disease Intervention/treatment Phase
Dehydration, Diverting Ileostomy, Loperamide Drug: Loperamide Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prospective Randomized Control Study on Effect of Post Operative Loperamide in Decreasing Readmission for Dehydration in Colorectal Patients After Diverting Ileostomies
Actual Study Start Date : October 7, 2014
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : December 31, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dehydration
Drug Information available for: Loperamide

Arm Intervention/treatment
No Intervention: Control
Experimental: Therapeutic
Patients randomized to this arm will be administered 4mg tid (three times daily) of loperamide from the day of discharge onwards. A total of duration of 14 days of medication will be administered
Drug: Loperamide
Loperamide 12mg per day (4mg t.i.d) for 2 weeks post discharge

Primary Outcome Measures :
  1. Incidence of 30 Day Readmission (Severe Dehydration) [ Time Frame: 30 day ]

Secondary Outcome Measures :
  1. Moderate Dehydration Resulting in Outpatient Visits or ER Intervention That is =/<24hrs That Did Not Require Hospital Admission [ Time Frame: 30 day ]
  2. Mild Dehydration - Subjective Report of Difficulty in Managing Fluid Balances and Stoma Care [ Time Frame: 30 days ]

Other Outcome Measures:
  1. Length of Index Admission [ Time Frame: 30 day ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Able to freely give written informed consent to participate in the study and have signed the Informed Consent Form;
  2. Males or females, age 18 and older at the time of study screening;
  3. American Society of Anesthesiologists (ASA) Class I-III (Appendix III) undergoing elective surgery

Exclusion Criteria:

  1. Mentally incompetent or unable or unwilling to provide informed consent or comply with study procedures
  2. American Society of Anesthesiologists (ASA) Class IV or V; emergency surgeries
  3. Children <18
  4. Pregnant patients
  5. Patients who have intra-abdominal sepsis or partial or intermittent bowel obstruction or enteritis
  6. Patients who are on long term steroids, opioids or antidiarrheals pre operatively
  7. Patients who are administered pro kinetics eg. Metoclopramide
  8. Patients with recurrent disease in their small bowel - Crohn's disease, or previous irradiated pelvis resulting in irradiation bowel disease
  9. End ileostomies

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02263365

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United States, California
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center
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Principal Investigator: Philip R Fleshner, MD Cedars-Sinai Medical Center

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Responsible Party: Phillip Fleshner MD, Director of Colorectal Residency, Cedars-Sinai Medical Center Identifier: NCT02263365     History of Changes
Other Study ID Numbers: Loperamide Dehydration
First Posted: October 13, 2014    Key Record Dates
Results First Posted: December 20, 2017
Last Update Posted: December 20, 2017
Last Verified: November 2017
Additional relevant MeSH terms:
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Water-Electrolyte Imbalance
Metabolic Diseases
Pathologic Processes
Gastrointestinal Agents