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
About this trial
This is an interventional trial for Prolonged Postoperative Ileus
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.
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
NCT ID
NCT01648972
First Posted
July 24, 2012
Last Updated
July 2, 2014
Sponsor
University of Auckland, New Zealand
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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