跳至主要内容
临床试验/CTRI/2025/11/098236
CTRI/2025/11/098236尚未招募不适用

The evaluation of robotic cholecystectomy versus laparoscopic cholecystectomy

Vydehi Institute of Medical Sciences & Research Centre1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年11月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
1
主要终点
Duration of surgery (in minutes)

研究概览

简要总结

Cholecystectomy, performed for gallstone disease and other benign gallbladder conditions, is one of the most common abdominal surgeries worldwide. Over the past three decades, laparoscopic cholecystectomy (LC) has become the gold standard due to its minimally invasive nature, shorter recovery, and reduced postoperative complications. However, its technical limitations—such as rigid instruments and two-dimensional imaging—pose challenges in complex cases. To address these, robotic-assisted cholecystectomy (RC) has emerged, offering enhanced visualization, wristed instrumentation, and improved ergonomics, which can aid in precise dissection, particularly in difficult anatomical situations**.** Despite its theoretical advantages, the clinical superiority of RC over LC remains uncertain. Several studies have reported similar outcomes in terms of postoperative pain, complications, and recovery, while also noting longer operative times and higher costs associated with RC. The justification for these increased resources in standard cases is still unclear. Moreover, much of the current evidence comes from retrospective studies with small sample sizes, lacking standardization and long-term outcomes. Given the rising adoption of robotic surgery, there is a clear need for prospective comparative studies. This study aims to assess the true clinical and economic value of RC versus LC, providing evidence-based guidance for surgical practice and resource optimization.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • Patients aged more than 18 years of age Diagnosed with symptomatic cholelithiasis or gall bladder polyps Eligible for minimally invasive surgery.

排除标准

  • Acute cholecystitis History of upper abdominal surgery Coagulopathy or uncorrected bleeding disorder Unfit for general anaesthesia Pregnant patients.

结局指标

主要结局

Duration of surgery (in minutes)

时间窗: Day of surgery

次要结局

  • Intraoperative complications(Day of surgery)
  • Postoperative pain assessed using the Visual Analogue Scale(6, 12, and 24 hours postoperatively)
  • Length of hospital stay(Day of Discharge)
  • Cosmetic satisfaction: Measured using a 5-point Likert scale(Day 7, Month 1, Month 2, Month 3 postoperatively)
  • Postoperative complications: Including wound infection, bile leak, or any readmission(Day 7, Month 1, Month 2, Month 3 postoperatively)

研究者

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

Shwetha Y

Vydehi institute of Medical Science and Research Centre

研究点 (1)

Loading locations...

相似试验

Comparing two different surgery methods for... | 临床试验