CTRI/2025/09/094352尚未招募不适用
Early Versus Delayed Laparoscopic Cholecystectomy in Moderately Severe and Severe Acute Biliary Pancreatitis : A Randomised Controlled Trial
Priti Ranjan Rout1 个研究点 分布在 1 个国家目标入组 118 人开始时间: 2025年9月20日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Recurrence of Acute Pancreatitis/ new onset Acute Cholecystitis/ Cholangitis or any other pancreatico biliary event requiring invasive intervention
研究概览
简要总结
The aim of the trial is to compare early ( same admission ) vs delayed ( after 6-8 weeks ) laparoscopic cholesystectomy in patients of moderately severe and severe acute biliary pancreatitis in terms of interim major pancreaticobiliary events and major surgical outcomes
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Moderately severe and Severe Acute biliary pancreatitis as per revised atlanta classification
- •Fit for surgery as per anaesthesia and absence of large collection in right upper quadrant of abdomen.
排除标准
- •Prior history of hepatobiliary surgery
- •ASA III or more
- •Significant comorbidity.
- •CKD, Congestive heart failure or decompensated cirrhosis
- •Refusal to give consent.
结局指标
主要结局
Recurrence of Acute Pancreatitis/ new onset Acute Cholecystitis/ Cholangitis or any other pancreatico biliary event requiring invasive intervention
时间窗: from date of randomisation to 1week, 3 week and 3 months after surgery
次要结局
- Minor surgical complication according to clavien dindo classification & comprehensive complication index(Day of surgery to 1week, 3 week & 3 months postoperative period)
- Need for drainage procedure of peripancreatic fluid collection prior to surgery(From randomisation to date of surgery)
- total operating time(skin incision to skin closure)
- Post operative hospital stay(From day of surgery to 3 months)
- Need for readmission or intervention(From randomisation to 3 months)
- Difficulty of the procedure as assessed by the surgeon(Intraoperative)
研究者
Priti Ranjan Rout
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI
研究点 (1)
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