Prolonged Postoperative Ileus Clinical Trial
— GAPOfficial title:
Randomised Double-blind Placebo-controlled Trial of Gastrografin in the Therapeutic Management of Prolonged Postoperative Ileus Following Elective Surgery.
| Verified date | July 2014 |
| Source | University of Auckland, New Zealand |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | New Zealand: Ethics Committee |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 0 |
| Est. completion date | July 2014 |
| Est. primary completion date | July 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
N/A
| Country | Name | City | State |
|---|---|---|---|
| New Zealand | Auckland City Hospital | Auckland | AKL |
| Lead Sponsor | Collaborator |
|---|---|
| University of Auckland, New Zealand |
New Zealand,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time from diagnosis (and administration of study drug) to resolution of prolonged postoperative ileus. | No | ||
| Secondary | Length of hospital stay (days) | Days | No |