Gastrografin in Postoperative Ileus

NCT ID: NCT01648972

Last Updated: 2014-07-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2014-07-31

Brief Summary

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After abdominal surgery there is a period of unavoidable dysfunction of the gut. During this time patients are often unable to eat and drink, and do not pass any flatus or stool. Though this resolves within a few days for most, there are a significant number (around 30%) who go on to have a prolonged period of this dysfunction known clinically as postoperative ileus. It has been clearly shown that this group of patients have worse health outcomes and spend a longer time in hospital.

The aim of this study is to trial a drug - gastrografin - in the management of prolonged postoperative ileus. Gastrografin is safe, economical, readily available, and has been used with great success in the similar condition of bowel obstruction. It is predicted that gastrografin will shorten the duration of a prolonged postoperative ileus, thus affording affected patients a better outcome from surgery.

Detailed Description

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Conditions

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Prolonged Postoperative Ileus

Study Groups

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Gastrografin

Group Type EXPERIMENTAL

Gastrografin

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Gastrografin

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age \> 18 years.
* Current inpatient following elective laparoscopic or open surgery.
* Classified as having prolonged postoperative ileus.
* Able to understand risks/benefits of the study.
* Able to give informed consent.

Exclusion Criteria

* Pregnancy.
* ASA of 4 or greater.
* Previous allergic reaction to gastrografin or iodinated contrast agents.
* Manifest hyperthyroidism.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Auckland, New Zealand

OTHER

Sponsor Role lead

Responsible Party

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A/Prof Ian Bissett

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Auckland City Hospital

Auckland, AKL, New Zealand

Site Status

Countries

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New Zealand

Other Identifiers

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UOA-ggRCT1

Identifier Type: -

Identifier Source: org_study_id

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