A Study to Compare Loperimide to Placebo for the Prevention of Excess Fluid Losses From the Stoma in Patients with New Loop Ileostomy.

Phase 3

• Conditions: High output ileostomy; Dehydration; Acute kidney failure; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon; Surgery - Other surgery

• Registration Number: ACTRN12614000180617
• Lead Sponsor: Hunter New England Local Health District

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-02-17
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

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 Criteria

-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

Study & Design

• Study Type: Interventional
• Study Design: Not specified