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

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2014
INTERVENTION: 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. CONDITION: Acute kidney failure Dehydration High output ileostomy PRIMARY OUTCOME: Incidence of high output ileostomy SECONDARY OUTCOME: Estimated glomerular filtration rate of less than ; 60 ml/min/1.73m2 Mean weight loss after hospital discharge Participant readmission rate Serum creatinine above 110 umol/L Serum sodium below 130 mmol/L or above 145mmol/L Stoma output more than 2 litres per day. Surgical complications, according to the validated Clavien Dindo surgical complication score Total hospital length of stay Weight loss in excess of 10% after discharge 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.
Epistemonikos ID: 36988cd65da45e1709de62edfe5b67f96f4a6c3d
First added on: Aug 23, 2024