Gastrografin in Postoperative Ileus (GAP)

University of Auckland, New Zealand

Status and phase: Completed; Phase 3; Phase 2

Conditions: Prolonged Postoperative Ileus

Treatments: Drug: Gastrografin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01648972

UOA-ggRCT1

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

0 participants in 2 patient groups, including a placebo group

Gastrografin

Experimental group

Treatment:

Drug: Gastrografin

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo