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临床试验/NCT07195643
NCT07195643已完成不适用

Predictive Factors of Drain Insertion After Laparoscopic Cholecystectomy: A Cohort Study

University of Baghdad1 个研究点 分布在 1 个国家目标入组 559 人开始时间: 2024年1月21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
559
试验地点
1
主要终点
Proportion of patients undergoing laparoscopic cholecystectomy who require intraoperative drain insertion

研究概览

简要总结

This study looks at when surgical drains are truly needed after laparoscopic gallbladder removal (laparoscopic cholecystectomy). Drains are sometimes placed during surgery to prevent fluid buildup or infection, but many studies show they are not always necessary. We reviewed 559 patients who had this surgery at Safeer Al-Husain Hospital in Karbala, Iraq. The goal of this study is to help doctors decide more carefully when to use drains, so patients can avoid unnecessary tubes and recover more quickly.

详细描述

Background:

Laparoscopic cholecystectomy (LC) is the standard treatment for symptomatic gallstones, offering benefits such as reduced pain, shorter hospital stays, and faster recovery. However, postoperative complications like bile leakage, hemorrhage, and infection remain concerns. Many surgeons use intraoperative drains routinely to prevent these complications, though evidence increasingly suggests selective use may be preferable. Few studies have systematically identified which patient or intraoperative factors predict the need for drain placement.

Objective:

To identify demographic, clinical, and intraoperative predictors of surgical drain placement after LC, enabling evidence-based, selective drain use.

Methods:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Underwent laparoscopic cholecystectomy (LC) at Safeer Al-Husain Hospital, Karbala, Iraq.
  • Both male and female patients.
  • Diagnosed with gallstone disease, including:
  • Chronic cholecystitis
  • Acute cholecystitis
  • Acute-on-chronic cholecystitis
  • Biliary colic

排除标准

  • Conversion from laparoscopic to open cholecystectomy prior to completion of the procedure.
  • Patients undergoing emergency surgery for gallbladder perforation with generalized peritonitis, where standard laparoscopic cholecystectomy was not feasible.

结局指标

主要结局

Proportion of patients undergoing laparoscopic cholecystectomy who require intraoperative drain insertion

时间窗: Immediately post-op, day zero

次要结局

  • Operative time(Day 0 (intraoperative period))
  • Trocar insertion technique(Intraoperative)
  • Gallbladder anatomy(Intraoperative)
  • Common bile duct anatomy(Intraoperative)
  • Number of clips used(Intraoperative)
  • Incidence of intraoperative bile or stone spillage(Day 0 (intraoperative period))
  • Gallbladder wall thickness(Baseline (preoperative imaging))
  • Presence of adhesions(Day 0 (intraoperative period))
  • Patient demographics(Baseline (before surgery))
  • Clinical presentation(Baseline (preoperative assessment))
  • Hepatic bed status(Intraoperative)
  • Gallbladder extraction technique(Intraoperative)
  • Other adverse events(Intraoperative)

研究者

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

Mohammedsadeq A. Shweliya

Principal Investigator, College of Medicine, University of Baghdad

University of Baghdad

研究点 (1)

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