Efficacy of Rectal Indomethacin in Prevention of Post-operative Pancreatitis After Pancreaticoduodenectomy - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Post-operative Pancreatitis
研究概览
简要总结
Pancreatico-duodenectomy is one of the commonly performed procedure for periampullary/distal cholangio/head of pancreas carcinoma. Post operative pancreatitis is an emerging concept, recently being studied as one of the most important contributing factor of Post-operative pancreatic fistula, which is one of the major complication of pancreatoduodenectomy. Rectal indomethacin, a type of non-steroidal anti-inflammatory drug, when given in a single dose has been shown to prevent pancreatitis in patients undergoing ERCP. In this study, we will be administering rectal indomethacin at the time of induction of anesthesia to the experimental arm of the study and compare the results in terms of incidence of post-operative pancreatitis in the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All consenting adults planned to undergo pancreatoduodenectomy,
排除标准
- •allergic reactions to NSAIDs
- •internal hemorrhoids
- •anti-platelet medications
研究组 & 干预措施
Group B
Standard Medical Treatment
干预措施: Standard Medical Treatment (Other)
Group A
Will be administered 100mg of Indomethacin Suppository sigle dose at the time of induction of anesthesia with Standard Medical Treatment
干预措施: Indomethacin suppository (Drug)
Group A
Will be administered 100mg of Indomethacin Suppository sigle dose at the time of induction of anesthesia with Standard Medical Treatment
干预措施: Standard Medical Treatment (Other)
结局指标
主要结局
Post-operative Pancreatitis
时间窗: first 30 days following pancreatoduodenectomy
次要结局
- intra-abdominal abscess(first 30 days following pancreatoduodenectomy)
- Length of ICU stay(First 30 days following pancreatoduodenectomy)
- Post-operative Pancreatic Fistula(first 30 days following pancreatoduodenectomy)
- delayed gastric emptying(First 30 days following pancreatoduodenectomy)
- Length of hospital stay(First 30 days following pancretoduodenectomy)
- risk factors of post-operative pancreatitis(first 30 days following pancreatoduodenectomy)