跳至主要内容
临床试验/NCT04405713
NCT04405713已完成不适用

Assessment of Different Timing for Early Laparoscopic Cholecystectomy in Acute Calcular Cholecystitis (Multicentric Study)

Mansoura University2 个研究点 分布在 1 个国家目标入组 900 人开始时间: 2018年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
900
试验地点
2
主要终点
the incidence of postoperative morbidity

研究概览

简要总结

The ideal timing for ELC continues to be debatable in patients with acute calculator cholecystitis (ACC). This study was planned to identify the impact of different ELC timing in ACC on surgical outcomes in terms of safety and efficacy

详细描述

This multicentric analysis involved of successive patients with ACC ELC between April 2018 and March 2020. Patients were divided into three groups according to the timing of the surgery: from the onset of symptoms within the first 3 days (group 1), between 4 and 7 days (group 2), and beyond 7 days (group 3). The primary outcome was the incidence of postoperative complications The secondary outcomes were conversion rate, blood loss, operative times, operational difficulty, the cost-benefit relationship, postoperative stay with each treatment line.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

Patients were divided into three groups according to the timing of the surgery: from the onset of symptoms within the first 3 days (group 1), between 4 and 7 days (group 2) and beyond 7 days (group 3).

入排标准

性别
All
接受健康志愿者

入选标准

  • ACC patients who underwent early LC

排除标准

  • Pregnancy, Acalculous cholecystitis, CBDS, Ascending cholangitis, Pancreatitis, ASA score 4, Patients scheduled for DLC with failed medical treatment.

结局指标

主要结局

the incidence of postoperative morbidity

时间窗: 30 DAYS

the incidence of postoperative morbidity during the 30th day of postoperative procedure

次要结局

  • blood loss(intraoperative)
  • conversion rate(INTRAOPERATIVE)
  • hospital stay(30 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ayman El Nakeeb

gastrointestinal surgical center, Mansoura University

Mansoura University

研究点 (2)

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