跳至主要内容
临床试验/CTRI/2025/12/098989
CTRI/2025/12/098989尚未招募不适用

Comparative study of monopolar electrocautery versus ultrasonic dissection of gallbladder in laparoscopic cholecystectomy

DR KSHETRIMAYUM ROMANCE SINGH1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年12月22日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
Operative time, intraoperative blood loss, gallbladder perforation rate, postoperative pain scores

研究概览

简要总结

This study is a prospective observational study evaluating the effectiveness and safety between surgeries performed using electrocautery and those performed using the curved jaw cordless ultrasonic dissector during laparoscopic cholecystectomy. Patient will be selected through consecutive sampling as they present for surgery and meet inclusion criteria. The choice of instrument will be based on availability and surgeon preference without any predefined allocation. The primary outcome measures include: operative time, intraoperative blood loss, gallbladder perforation rate, postoperative pain scores, postoperative complications. Data will be statistically analysed using appropriate tests, and the results will help determine whether the curved jaw cordless ultrasonic dissector offers significant clinical advantages over traditional electrocautery in terms of effectiveness, safety and patient outcomes.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Diagnosed with cholelithiasis admitted for laparoscopic cholecystectomy under general anaesthesia.

排除标准

  • Acute or gangrenous cholecystitis, gallbladder malignancy, coagulopathies or bleeding disorders, patient with jaundice, use of instruments other than the intended dissector instruments, conversion to open surgery.

结局指标

主要结局

Operative time, intraoperative blood loss, gallbladder perforation rate, postoperative pain scores

时间窗: 2years

次要结局

未报告次要终点

研究者

发起方
DR KSHETRIMAYUM ROMANCE SINGH
申办方类型
Other [Self ]
责任方
Principal Investigator
主要研究者

KSHETRIMAYUM ROMANCE SINGH

REGIONAL INSTITUTE OF MEDICAL SCIENCES

研究点 (1)

Loading locations...

相似试验