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Gastrografin in Postoperative Ileus (GAP)

Primary Purpose

Prolonged Postoperative Ileus

Status
Completed
Phase
Phase 2
Locations
New Zealand
Study Type
Interventional
Intervention
Gastrografin
Placebo
Sponsored by
University of Auckland, New Zealand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional trial for Prolonged Postoperative Ileus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Auckland City Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Gastrografin

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Time from diagnosis (and administration of study drug) to resolution of prolonged postoperative ileus.

Secondary Outcome Measures

Length of hospital stay (days)

Full Information

First Posted
July 24, 2012
Last Updated
July 2, 2014
Sponsor
University of Auckland, New Zealand
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1. Study Identification

Unique Protocol Identification Number
NCT01648972
Brief Title
Gastrografin in Postoperative Ileus
Acronym
GAP
Official Title
Randomised Double-blind Placebo-controlled Trial of Gastrografin in the Therapeutic Management of Prolonged Postoperative Ileus Following Elective Surgery.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Auckland, New Zealand

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prolonged Postoperative Ileus

7. Study Design

Study Phase
Phase 2, Phase 3

8. Arms, Groups, and Interventions

Arm Title
Gastrografin
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Gastrografin
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Time from diagnosis (and administration of study drug) to resolution of prolonged postoperative ileus.
Secondary Outcome Measure Information:
Title
Length of hospital stay (days)
Time Frame
Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Auckland City Hospital
City
Auckland
State/Province
AKL
ZIP/Postal Code
1010
Country
New Zealand

12. IPD Sharing Statement

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Gastrografin in Postoperative Ileus

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