A RCT to compare the gall bladder retrieval from epigastric versus umbilical port in laparoscopic cholecystectomy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 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 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 gall bladder diseases (symptomatic gall stones, GB polyps).
- •Patients in whom informed consent could be obtained.
排除标准
- •Acute cholecystitis.
- •Empyema gall bladder.
- •Mucocele of GB.
- •Suspected/ proven malignancy of GB.
- •Patients in whom laparascopic 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 bybthe patients with VAS score (0-10) at 6hrs, 12 hrs, 24hrs and 48 hrs following surgery.
次要结局
- 1. To assess the ease of retrieval of Gall bladder.(2. To assess the time taken for retrieval of gall bladder following dissection from liver bed.)