跳至主要内容
临床试验/CTRI/2024/09/074344
CTRI/2024/09/074344尚未招募不适用

Preoperative and intraoperative risk factors associated with conversion of laparoscopic cholecystectomy to open cholecystectomy – A Prospective Observational study

Uttar pradesh university of Medical sciences1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2024年10月11日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
250
试验地点
1
主要终点
Male gender ,old age ,history of previous abdominal surgery can be factors for conversion.

研究概览

简要总结

One of the most common causes of abdominal pain is the presence of gallstons.Cholecystectomy is the only effective management of symptomatic gallstones, with 93% of gallbladder disease problems referred to surgeons.

Laparoscopic cholecystectomy (LC) is a standard treatment for gallstone disease. LC results in a lower overall complication rate and shorter postoperative hospital stay compared to open cholecystectomy (OC).

Identifying preoperative patient-related factors, anticipating the need to convert from laparoscopic cholecystectomy to open surgery, can help identify high-risk patients and redefine surgical strategy in this group. These predictive conversion factors can also improve patient safety and increase the cost-effectiveness of gallstone treatment. 

The study will be taking into account all patients planned for laparoscopic cholecystectomy, irrespective of their preoperative findings, so as to remove the operator bias.

The study will be taking another step to bring to the table a scoring method, to advance the development of research into the stream of cholecystectomy.

研究设计

研究类型
Observational

入排标准

年龄范围
0.00 Day(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Patients admitted with clinical diagnosis of cholelithiasis and planned for laparoscopic cholecystectomy.
  • Patients able to give informed consent.

排除标准

  • Critically ill patients at high risk.
  • Patients with suspected or confirmed gall bladder cancer.
  • Patient not giving consent to be a part of study.
  • On further evaluation of the patient, different final diagnosis was confirmed.

结局指标

主要结局

Male gender ,old age ,history of previous abdominal surgery can be factors for conversion.

时间窗: At Baseline

次要结局

  • Raised ALP levels can be related to presence of CBD stones found intraoperatively.(Development of constitutional symptoms postoperatively can be related to preoperative variables.)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Shesh Kumar

Uttar Pradesh University of Medical Sciences, Saifai, Etawah

研究点 (1)

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