A Comparative study between conventional four port versus three port laparoscopic cholecystectomy.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- To compare the clinical outcomes of conventional four port laparoscopic cholecystectomy versus three port laparoscopic cholecystectomy in patients undergoing elective laparoscopic cholecystectomy.
研究概览
简要总结
This study will compare both the conventional gold standard four port laparoscopic cholecystectomy and upcoming three port.
Hypothesis- there is a significant difference in the clinical outcomes of conventional four port and three port laparoscopic cholecystectomy, indicating that one technique may offer advantages over the other in terms of patient recovery, pain management, and overall surgical efficiency without putting the patient in any added risk. Comparison will be made on the basis of:
Intraoperative outcomes: operative time (in minutes), intraoperative bleeding, biliary spillage, biliary injury, and postoperative outcomes: postoperative pain (vas scale at 6, 12, and 24 hours), dosage of analgesic used in grams (gm), hospital stay in days, time for return to activities of daily living in days, postoperative complications (biliary spillage, biliary injury, bleeding) and patient satisfaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 12.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with symptomatic gallstone disease who are candidates for elective laparoscopic cholecystectomy.
- •Patients with benign gallbladder polyps (greater than 10 mm).
- •Ability to give written informed consent and comply with the study protocol and follow-up.
排除标准
- •Acute cholecystitis or other severe inflammation requiring emergency surgery Cholelithiasis with choledocholithiasis Gallstone induced pancreatitis Suspected malignancy or gallbladder mass Patients with history of upper abdominal surgery Morbid obesity (BMI greater or equal to 40) Patients unfit for anaesthesia Pregnant females Patient with liver cirrhosis/ portal hypertension.
结局指标
主要结局
To compare the clinical outcomes of conventional four port laparoscopic cholecystectomy versus three port laparoscopic cholecystectomy in patients undergoing elective laparoscopic cholecystectomy.
时间窗: 1 Week
次要结局
- To compare operative & postoperative parameters between conventional four port & three port laparoscopic cholecystectomy in terms of-
研究者
Dr Vinali Gupta
Shri Ram Murthi Samarak, Institute of Medical Sciences