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Gastrografin in Postoperative Ileus (GAP)

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ClinicalTrials.gov Identifier: NCT01648972
Recruitment Status : Completed
First Posted : July 25, 2012
Last Update Posted : July 4, 2014
Sponsor:
Information provided by (Responsible Party):
A/Prof Ian Bissett, University of Auckland, New Zealand

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.


Condition or disease Intervention/treatment Phase
Prolonged Postoperative Ileus Drug: Gastrografin Drug: Placebo Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Official Title: Randomised Double-blind Placebo-controlled Trial of Gastrografin in the Therapeutic Management of Prolonged Postoperative Ileus Following Elective Surgery.
Study Start Date : September 2012
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Gastrografin Drug: Gastrografin
Placebo Comparator: Placebo Drug: Placebo



Primary Outcome Measures :
  1. Time from diagnosis (and administration of study drug) to resolution of prolonged postoperative ileus.

Secondary Outcome Measures :
  1. Length of hospital stay (days) [ Time Frame: Days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01648972


Locations
New Zealand
Auckland City Hospital
Auckland, AKL, New Zealand, 1010
Sponsors and Collaborators
University of Auckland, New Zealand

Responsible Party: A/Prof Ian Bissett, Associate Professor, University of Auckland, New Zealand
ClinicalTrials.gov Identifier: NCT01648972     History of Changes
Other Study ID Numbers: UOA-ggRCT1
First Posted: July 25, 2012    Key Record Dates
Last Update Posted: July 4, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
Ileus
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases