Randomised Double-blind Placebo-controlled Trial of Gastrografin in the Therapeutic Management of Prolonged Postoperative Ileus Following Elective Surgery.
| Registry | NCT01648972, acronym GAP |
|---|---|
| Status | Completed |
| Phase | Phase 2 / Phase 3 |
| Study type | Interventional |
| Sponsor | University of Auckland, New Zealand (Other) |
| Conditions | Prolonged Postoperative Ileus |
| Interventions | Gastrografin, Placebo (Drug) |
| Dates | start 2012-09-01, primary completion 2014-07-01, completion 2014-07-01, first posted 2012-07-25, last updated 2014-07-04 |
| Locations | 1 site in New Zealand |
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All trials for Prolonged Postoperative Ileus All trials of Gastrografin All trials of Placebo
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Gastrografin | Experimental | Drug: Gastrografin | |
| Placebo | Placebo comparator | Drug: Placebo |
Sex: All, ages: 18 Years to any
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 | City | Country | Status |
|---|---|---|---|
| Auckland City Hospital | Auckland, AKL | New Zealand |