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临床试验/NCT05728073
NCT05728073已完成不适用

Does Subtotal Cholecystectomy Rate for Acute Cholecystitis Change With a Previous ERCP?

Bakirkoy Dr. Sadi Konuk Research and Training Hospital1 个研究点 分布在 1 个国家目标入组 470 人开始时间: 2022年12月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
470
试验地点
1
主要终点
Subtotal Cholecystectomy Rate

研究概览

简要总结

Study is designed to investigate whether the history of ERCP is associated with subtotal cholecystectomy rates in patients underwent laparoscopic cholecystectomy operations with the diagnosis of acute cholecystitis.

详细描述

The results of patients who underwent surgery for acute cholecystitis in a single center between January 2016 and December 2019 were included and evaluated retrospectively.

Primary outcome was subtotal cholecystectomy rate. Secondary outcomes were conversion to open, complications and serious complications. Within examining demographic findings, operative records (rates for subtotal cholecystectomy and conversion to open, operative duration) and follow-up results (postoperative complications, serious complications, length of hospital stay and mortality) for all cases were investigated. Complications that Clavien-Dindo Score ≥ 3 accepted as serious complication. Intraoperative detection of gallbladder perforation was also noted and included in comparison. Any biliary tract complication that needed any percutaneous or endoscopic intervention to handle was named as "biliary leak" in the study.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients operated with the diagnosis of acute cholecystitis with an age greater or equal to 18 years old in a single center between January 2016 and December 2019

排除标准

  • Initial and direct preferance of open method
  • Being diagnosed with malignity after histopathological evaluation
  • Being operated just before one week after ERCP or after more than six weeks after ERCP

结局指标

主要结局

Subtotal Cholecystectomy Rate

时间窗: Intraoperative

Rate of patients needed subtotal cholecystectomy after initial intent of starting laparoscopic to the cholecystectomy

次要结局

  • Conversion to open(Intraoperative)

研究者

发起方
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Turgut Donmez

Ass. Prof. Dr.

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

研究点 (1)

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