A comparative study of outcomes between umbilical and epigastric port retrieval of gall bladder in elective laparoscopic cholecystectomy for gall stone disease: A double blinded randomized controlled trial
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Postoperative pain assessment using VAS score
研究概览
简要总结
Laparoscopic cholecystectomy is gold standard technique for gall bladder diseases. Gallbladder can be extracted either from the epigastric port or umbilical port. Regarding choice of exit port and use of endobag for retrieval, the SAGES guidelines for biliary surgery state “With no data to guide choice of technique, the gallbladder may be extracted as the surgeon prefers (2010) (Level III, Grade C)â€. Multiple studies including RCT’s and Meta analysis have been performed comparing both the ports for gallbladder retrieval in multiport LC, however none of the studies has given a clear message regarding the optimal port site for retrieval.
The purpose of this study is to define the optimal port for gallbladder retrieval by comparing the two ports with respect to parameters like postoperative pain, total requirement of postoperative analgesia, gallbladder retrieval time and port site infection (SSI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •Age between 18 years to 65 years 2) All patients consenting for the study 3) All patients undergoing elective laparoscopic cholecystectomy for gall stone disease.
排除标准
- •Patients with bmi more than 40 2) Patients with suspected malignancy 3) Intraoperative bile or stone spillage during dissection 2) Conversion to open procedure.
结局指标
主要结局
Postoperative pain assessment using VAS score
时间窗: 6 hours, 12 hours and 24 hours.
次要结局
- To estimate total requirememt of postoperative analgesics
研究者
Ammapalem Satish
All India Institute of Medical Sciences, Rishikesh.
