A Study to Compare Loperimide to Placebo for the Prevention of Excess Fluid Losses From the Stoma in Patients with New Loop Ileostomy.
A Double-blind Randomised, Placebo-controlled Trial to Assess the Efficacy of Loperamide versus Placebo as Post-operative Prevention of High Output Ileostomy Losses in Patients with New Loop Ileostomy.
Hunter New England Local Health District
86 participants
Aug 28, 2014
Interventional
Conditions
Summary
One of the commonest complications of an ileostomy is the potential loss of a large amount of fluids and salts from the ileostomy, and this is called a high output ileostomy. A high output ileostomy can cause a person to become dehydrated and when the losses are large enough, it can lead to kidney failure, and re-presentation to hospital, with admission to hospital with long hospital stay The purpose of this study is to see if large ileostomy output can be prevented from occurring, rather than waiting for it to happen and then treating it.
Eligibility
Inclusion Criteria3
- Written informed consent
- All adult (>18 years) patients undergoing elective or semi-urgent booked operations involving a loop ileostomy at the participating hospitals.
- Must have passed flatus post-operatively, tolerating diet and no signs and symptoms of ileus.
Exclusion Criteria4
- Refuse or are unable to give written informed consent to participate in the study, or
- Have a known allergy or adverse drug reaction to loperamide
- Pregnant or lactating females
- Have a eGFR less than 60ml/min/1.73m3 pre-operatively
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Interventions
Loperamide 4mg three times per day orally for 3 months commencing on day of first passage of flatus post-operatively. Patients will weigh themselves at home daily and keep a diary of stoma output. Empty drug packs will be returned to pharmacy for drug accountability.
Locations(2)
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ACTRN12614000180617