跳至主要内容
临床试验/NCT06244589
NCT06244589已完成不适用

Evaluation of Risk Factors Leading to Conversion From Laparoscopic Cholecystectomy to Open Surgery: A Retrospective Controlled Study

Sisli Hamidiye Etfal Training and Research Hospital2 个研究点 分布在 2 个国家目标入组 1,695 人开始时间: 2024年2月12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
1,695
试验地点
2
主要终点
Open-conversion rate

研究概览

简要总结

This retrospective controlled study aims to evaluate risk factors that affect open conversion in laparoscopic cholecystectomy. Patient characteristics, medical history, biochemical and radiological studies of the patient will searched from the hospital database and factors affecting open conversion will be analysed.

详细描述

Cholecystectomy is a commonly performed procedure in general surgical practice, and with advancements in technology, it is widely conducted using the laparoscopic method. Despite the decreasing trend in open surgical procedures with increasing experience and technological developments, the literature reports conversion to open surgery in laparoscopic cholecystectomy ranging from 2% to 15%. Although some studies exist regarding patient groups at risk of conversion to open surgery, the current literature is insufficient to draw a clear conclusion on this matter. This study aims to evaluate risk factors for conversion to open surgery by examining cases of laparoscopically initiated cholecystectomy.

The study will be conducted retrospectively by reviewing archive records. Patients operated for cholecystectomy will be included. Patients that open surgical method used from start will be excluded from study. Age, comorbidities (ASA score), laboratory findings (leukocyte count and CRP), imaging findings (abdominal ultrasound, CT, or MRI), history of previous abdominal surgery, history of ERCP, and history of pancreatitis will be evaluated. Laparoscopic cholecystectomy cases will be compared with open-conversion cholecystectomies to assess factors influencing the conversion.

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
None

入排标准

年龄范围
18 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged between 18 and 95 years old.
  • Operated for gallbladder disease (Cholecystectomy)
  • Surgery must started with laparoscopic approach

排除标准

  • Open surgery from the start
  • Cholecystectomy as a part of bigger surgical intervention (Such as pancreaticoduodenectomy)

结局指标

主要结局

Open-conversion rate

时间窗: Immediately after the surgery

The rate of cases converted to open surgery among all laparoscopic cholecystectomy cases.

次要结局

  • Postoperative complication rate(1 months after the surgery)
  • Incidental gallbladder malignancy rate(1 months after the surgery)

研究者

发起方
Sisli Hamidiye Etfal Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Burak Dincer

Burak Dinçer, MD

Sisli Hamidiye Etfal Training and Research Hospital

研究点 (2)

Loading locations...

相似试验