Randomised Double-blind Placebo-controlled Trial of Gastrografin in the Therapeutic Management of Prolonged Postoperative Ileus Following Elective Surgery.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 试验地点
- 1
- 主要终点
- Time from diagnosis (and administration of study drug) to resolution of prolonged postoperative ileus.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Pregnancy.
- •ASA of 4 or greater.
- •Previous allergic reaction to gastrografin or iodinated contrast agents.
- •Manifest hyperthyroidism.
研究组 & 干预措施
Gastrografin
干预措施: Gastrografin (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Time from diagnosis (and administration of study drug) to resolution of prolonged postoperative ileus.
次要结局
- Length of hospital stay (days)(Days)
研究者
A/Prof Ian Bissett
Associate Professor
University of Auckland, New Zealand