A RCT to compare gall bladder retrieval from epigastric versus umbilical port in laparoscopic cholecystectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To compare the post operative pain at the port site in both groups
研究概览
简要总结
Laparoscopic Cholecystectomy is one of the most common procedures performed by general surgeons. However, there have been no studies in our setting to evaluate the umbilical vs epigastric port site gall bladder extraction and its relation to post-operative pain as well as other complications related to port site. Despite a lot of literature available on laparoscopic cholecystectomy, still it is not clear which port site is best to extract gall bladder. This current study aims to explore a better port for gallbladder retrieval in laparoscopic cholecystectomy in terms of pain outcome, time taken for delivery of gall bladder out of abdomen and ease of extraction by randomized controlled trial study to be conducted at our tertiary care teaching hospital.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 16.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •16-80 years old patients undergoing elective laparoscopic cholecystectomy for benign GB diseases (symptomatic gallstones, GB polyps) Patients in whom informed consent could be obtained.
排除标准
- •Acute cholecystitis Empyema GB Mucocele of GB, Suspected/proven malignancy of GB Patients in whom laparoscopic cholecystectomy has to be converted in open procedure Patients who are chronic users of analgesic medicines and steroids.
结局指标
主要结局
To compare the post operative pain at the port site in both groups
时间窗: Pain score will be graded by the patient with VAS score (0-10) at 6 hours, 12 hours, 24 hours and 48 hours following surgery
次要结局
- To assess the ease of retrieval of gall bladder(The difficulty in GB retrieval will be graded by the operative surgeon by using VAS score (0- easy retrieval, 10- very difficult retrieval))
- To assess the time taken for retrieval of gall bladder following dissection from liver bed(The time taken for removal of the gall bladder following dissection to retrieval in minutes)
- To assess the incidence of port site infection(Port site infection to be graded by South Hampton wound scoring system on day 7, 14 and 06 weeks following surgery)