CTRI/2025/08/092774尚未招募4 期
Comparison of Postoperative Pain Between Standard 4-Port Laparoscopic and Robotic Cholecystectomy: An Open-Label Randomised Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- To compare postoperative pain between standard 4 port laparoscopic cholecystectomy
研究概览
简要总结
An open label randomised controlled trial comparing the post operative pain between the patients of symptomatic gall stone disease following standard 4 port laparoscopic cholecystectomy and robotic cholecystectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA Grade 1,2 and 3
- •BMI below 35 kg/m2
- •Symptomatic Cholelithiasis planned for routine OT.
排除标准
- •Acute cholycestitis and associated complications like Pyocelele, emphysematous or gangrenous cholecystitis
- •Emergency cholecystectomy
- •History of choledocholithiasis
- •Presence of umbilical hernia
- •History of upper abdominal surgery
- •Pregnant women
- •History of chronic analgesic medication intake
- •Known case of chronic kidney disease
- •Unfit for general anesthesia
- •Refusal of consent for participation in study.
结局指标
主要结局
To compare postoperative pain between standard 4 port laparoscopic cholecystectomy
时间窗: On admission (baseline), 6 hours after | surgery, 24 hours after surgery, 7 days after surgery.
and robotic cholecystectomy.
时间窗: On admission (baseline), 6 hours after | surgery, 24 hours after surgery, 7 days after surgery.
次要结局
- To compare the operative time between standard 4 port laparoscopic cholecystectomy(and robotic cholecystectomy.)
- To compare the conversion rate from laparoscopic to open procedure in standard 4 port(laparoscopic cholecystectomy & robotic to laparoscopic/open procedure in robotic)
- To compare the overall complication rate in terms of bile duct injury, surgical site(infections(SSI), port site pain,port site hernia, port site sinus & re-admission rates)
研究者
Ankadala Anirudh Babu
All India Institute of Medical Sciences
研究点 (1)
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