Efficacy of Rectal Indomethacin in prevention of post-operative pancreatitis after pancreaticoduodenectomy – a randomized controlled trial
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Incidence of 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
- Permuted block randomization, fixed
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •All consenting adults planned to undergo pancreatoduodenectomy.
排除标准
- •Patients refusing to consent
- •History of asthma
- •History of allergic reactions to NSAIDs
- •History of renal dysfunction or CKD
- •E/o Internal hemorrhoids on examination
- •Patients on Anti-platelet drugs.
结局指标
主要结局
Incidence of Post-operative Pancreatitis
时间窗: Within 30 days of surgery
次要结局
- Post-operative pancreatic fistula rate(within 30 days of surgery)
- Post-pancreaticoduodenectomy hemorrhage rate(within 30 days of surgery)
- Delayed Gastric emptying rate(within 30 days of surgery)
- Intra-abdominal collections/abscess rates(within 30 days of surgery)
- Duration of ICU stay(within 30 days of surgery)
- Length of Hospital Stay(within 30 days of surgery)
- Risk factors for post-operative pancreatitis(within 30 days of surgery)