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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

July 24, 2012
July 25, 2012
July 4, 2014
September 2012
July 2014   (Final data collection date for primary outcome measure)
Time from diagnosis (and administration of study drug) to resolution of prolonged postoperative ileus.
Same as current
Complete list of historical versions of study NCT01648972 on ClinicalTrials.gov Archive Site
Length of hospital stay (days) [ Time Frame: Days ]
• Length of hospital stay (days). • Time to passage of flatus. • Time to passage of stool. • Time to toleration of light/full oral diet. • 30 day re-admission rate.
Not Provided
Not Provided
 
Gastrografin in Postoperative Ileus
Randomised Double-blind Placebo-controlled Trial of Gastrografin in the Therapeutic Management of Prolonged Postoperative Ileus Following Elective Surgery.

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.

Not Provided
Interventional
Phase 2
Phase 3
Not Provided
Prolonged Postoperative Ileus
  • Drug: Gastrografin
  • Drug: Placebo
  • Experimental: Gastrografin
    Intervention: Drug: Gastrografin
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
Not Provided
July 2014
July 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
New Zealand
 
 
NCT01648972
UOA-ggRCT1
No
Not Provided
Not Provided
A/Prof Ian Bissett, University of Auckland, New Zealand
University of Auckland, New Zealand
Not Provided
Not Provided
University of Auckland, New Zealand
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP