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Trial details imported from ClinicalTrials.gov
Ethics application status
Gastrografin in Postoperative Ileus
Randomised Double-blind Placebo-controlled Trial of Gastrografin in the Therapeutic Management of Prolonged Postoperative Ileus Following Elective Surgery.
Universal Trial Number (UTN)
Prolonged Postoperative Ileus
Oral and Gastrointestinal
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Description of intervention(s) / exposure
Treatment: Drugs - Gastrografin
Treatment: Drugs - Placebo
Experimental: Gastrografin -
Placebo Comparator: Placebo -
Treatment: Drugs: Gastrografin
Treatment: Drugs: Placebo
Intervention code 
Comparator / control treatment
Primary outcome 
Time from diagnosis (and administration of study drug) to resolution of prolonged postoperative ileus.
Secondary outcome 
Length of hospital stay (days)
Key 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.
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
- ASA of 4 or greater.
- Previous allergic reaction to gastrografin or iodinated contrast agents.
- Manifest hyperthyroidism.
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment
Methods used to generate the sequence in which subjects will be randomised (sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
Statistical methods / analysis
Reason for early stopping/withdrawal
Accrual to date
University of Auckland, New Zealand
Ethics application status
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.
Trial related presentations / publications