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Gastrografin in Postoperative Ileus (GAP)

This study is currently recruiting participants.
Verified October 2012 by University of Auckland, New Zealand
Sponsor:
Information provided by (Responsible Party):
A/Prof Ian Bissett, University of Auckland, New Zealand
ClinicalTrials.gov Identifier:
NCT01648972
First received: July 24, 2012
Last updated: October 1, 2012
Last verified: October 2012
History of Changes
  Purpose

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 Intervention Phase
Prolonged Postoperative Ileus
 Drug: Gastrografin
Drug: Placebo
 Phase 2
Phase 3

Study Type: Interventional
Official Title: Randomised Double-blind Placebo-controlled Trial of Gastrografin in the Therapeutic Management of Prolonged Postoperative Ileus Following Elective Surgery.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Auckland, New Zealand:

Primary Outcome Measures:
  • Time from diagnosis (and administration of study drug) to resolution of prolonged postoperative ileus. [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Length of hospital stay (days) [ Time Frame: Days ] [ Designated as safety issue: No ]

Study Start Date: September 2012
Arms Assigned Interventions
Experimental: Gastrografin Drug: Gastrografin
Placebo Comparator: Placebo Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01648972

Contacts
Contact: Ian P Bissett, MD FRACS +64 21 347 442 i.bissett@auckland.ac.nz
Contact: Ryash Vather, MBChB +64 21 210 2024 r.vather@gmail.com

Locations
New Zealand
Auckland City Hospital Recruiting
Auckland, AKL, New Zealand, 1010
Contact: Ryash Vather, MBChB     +64 21 210 2024     r.vather@gmail.com    
Principal Investigator: Ian Bissett, MD FRACS            
Sponsors and Collaborators
University of Auckland, New Zealand
  More Information

No publications provided

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
Study First Received: July 24, 2012
Last Updated: October 1, 2012
Health Authority: New Zealand: Ethics Committee

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

ClinicalTrials.gov processed this record on May 16, 2013