NCT07234136已完成不适用
Cholecystectomy TIming for Mild Acute Biliary Pancreatitis [CTIMAP]: a Società Lombarda di Chirurgia Observational Study
Fondazione IRCCS Policlinico San Matteo di Pavia1 个研究点 分布在 1 个国家目标入组 445 人开始时间: 2022年4月12日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 445
- 试验地点
- 1
- 主要终点
- Rate of 6-month readmission due to GRE after hospitalization for MABP
研究概览
简要总结
CTIMAP is a prospective multicenter observational study on patients with Mild Acute Biliary Pancreatitis (MABP) treated with Same Admission Cholecystectomy (SAC) and Interval Cholecystectomy (IC). The rationale of this study is to investigate the timing of cholecystectomy after MABP applied by Lombard surgeons and compare SAC and IC, with the hypothesis that SAC would reduce the risk of recurrent Gallstones Related Events (GRE) without increasing the difficulty of surgery and postoperative complications.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •to be admitted with a diagnosis of acute pancreatitis, as defined according to 2012 Atlanta Criteria
- •pancreatitis is mild as defined according to 2012 Atlanta Criteria
- •the etiology of pancreatitis is a gallstone related (finding of stones or sludge in the gallbladder on in the main biliary duct)
- •be greater than or equal to 18 years old
- •provide signed and dated informed consent form
- •willing to comply with all study procedures and be available during the study
排除标准
- •pregnancy or lactation
- •pancreatitis not related to a gallstone etiology
- •chronic pancreatitis
- •moderately severe or severe pancreatitis
- •alcohol abuse
- •anything that would place the individual at increased risk or prevent the individual's full compliance with or completion of the study.
结局指标
主要结局
Rate of 6-month readmission due to GRE after hospitalization for MABP
时间窗: 6 months
次要结局
- 30-day postoperative complications rate after SAC and after IC in patients with MABP(Day 30)
- 30-day postoperative biliary complications rate after SAC and after IC in patients with MABP(Day 30)
- 30-day postoperative mortality rate after SAC and after IC in patients with MABP(Day 30)
- Intraoperative complication rate during SAC and IC(Day of SAC or IC)
- Rate of bail out procedures during SAC and IC(Day of SAC or IC)
- Conversion to open laparotomy rate during SAC and during IC in patients with MABP(Day of SAC or IC)
- Operative times (minutes) of SAC and of IC in patients with MABP(Day of SAC or IC)
- Postoperative length of stay (PO-LOS) after SAC and after IC in patients with MABP(At discharge)
- Total length of stay (T-LOS) of patients with MABP treated with SAC and with IC(At discharge)
- Rate of patients who after six months after discharge did not receive cholecystectomy (no-cholecystectomy group)(6 months after discharge)
研究者
Marcello Maestri
MD
Fondazione IRCCS Policlinico San Matteo di Pavia
研究点 (1)
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