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.

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000180617

Acronym

ALPHI Study

Enrollment

Registered

2014-02-17

Start date

2014-08-28

Completion date

2016-07-12

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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

Outcome results