Loperamide vs. Placebo's Effect on Ileostomy Output: A Clinical Randomized Blinded Cross-over Study

Loperamide vs. Placebo's Effect on Ileostomy Output: A Clinical Randomized Blinded Cross-over Study

Sponsors

Lead Sponsor: Odense University Hospital

Source Odense University Hospital
Brief Summary

Clinical experience show limited effect of the drug Loperamide used to decrease output in stoma patients. Therefore the investigators see the need for a randomized blinded clinical trial to determine the effect of Loperamide opposite Placebo. Loperamide will be evaluated in relation to the following parameters - Change in ileostomy output in g/day in relation to oral intake - Quantification of the change in intestinal transit time using a radiopaque marker - The patient´s own assessment on which period they received Loperamide or Placebo

Detailed Description

The aim of this study is to quantify the effect of Loperamide on ileostomy output in patients operated for rectal cancer, ulcerative colitis and in patients with short bowl syndrome. These patients are recruited through The Department of Surgery and The Department of Gastroenterology, University Hospital Odense. The effect of Loperamide will be evaluated against Placebo in relation to the following parameters: - Change in ileostomy output in g/day in relation to oral intake - Quantification of the change in intestinal transit time using a radiopaque marker - The patient´s own assessment on which period they received Loperamide or Placebo Construction of a stoma is a frequently used part of the surgical treatment of intestinal cancer and chronic intestinal inflammation. More than 60% of patients with an ileostomy develop dehydration and loss of salts and minerals, due to an excessive stoma output. The most common method used to reduce stoma output is Imodium® ( Loperamide ). The effect has never been studied extensively, probably because it is an over the counter medicine. The treatment is relatively expensive and also subject to side effects, even if they are mild. Therefore, the investigators found it relevant to perform a clinical study to determine the effect. The results will be important for future patient treatment. The study is a clinical blinded randomized crossover study. The study includes three types of patients. Patients operated for rectal cancer or ulcerative colitis with a temporary or permanent ileostomy, and patients with short bowel syndrome with a permanent ileostomy. The first two types of patients will be recruited through two ways. - During hospitalization in connection to their operation at The Department of Surgery, University Hospital Odense. The patients are offered inclusion into the study either before or after surgery depending upon the clinical situation. For those who consent and fulfills the inclusion criteria, the study starts up on 7th day after surgery. - Through their regular controls in the stoma clinic. Patients with short bowel syndrome are offered inclusion through their contact with The Department of Gastroenterology, University Hospital Odense, if they meet the criteria for inclusion. Patients will undergo to periods during the study. They will be randomized to start with either Loperamide or Placebo. Each period consists of 3 days. Day 1 - Uploading of the drug Day 2 - Collecting of stoma output when necessary Day 3 - Radiopaque marker and collection of stoma output every two hours After 7 days without medicine intake the patient starts the second period with the opposite drug. During day 2-3 the patient will register and weigh all food and fluid intake.

Overall Status Terminated
Start Date 2014-10-01
Completion Date 2015-08-01
Primary Completion Date 2015-08-01
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Output weight 2 days
Secondary Outcome
Measure Time Frame
Gastrointestinal transit time 10 hours
Enrollment 12
Condition
Intervention

Intervention Type: Drug

Intervention Name: Loperamide

Description: 12 mg Loperamide each day for three days

Arm Group Label: Loperamide

Other Name: Imodium

Intervention Type: Drug

Intervention Name: Placebo

Description: 6 tablets daily for three days

Arm Group Label: Placebo

Eligibility

Criteria:

Inclusion Criteria: - Operation for rectal cancer or ulcerative colitis an ileostomy (loop or end ileostomy within the last 7 days) OR - ileostomy patient with contact to the stoma clinic OR - Short bowel syndrome with a permanent ileostomy - signed consent form Exclusion Criteria: - Complications associated with surgery - Non-radical surgery - Chemotherapy - Poor compliance - Other serious illness

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Niels Qvist, MD, DMsc Study Director Odense University Hospital, Department of Surgery A, Denmark
Location
Facility: Odense University Hospital, Surgical Department A
Location Countries

Denmark

Verification Date

2016-10-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Odense University Hospital

Investigator Full Name: Niels Qvist

Investigator Title: Professor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Loperamide

Type: Active Comparator

Description: Patients will take the drug for three days. Day 1 - uploading with the drug Day 2 - collecting output when necessary Day 3 - radiopaque marker and collection of output every two hours

Label: Placebo

Type: Placebo Comparator

Description: Patients will take the drug for three days. Day 1 - uploading with the drug Day 2 - collecting output when necessary Day 3 - radiopaque marker and collection of output every two hours

Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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