跳至主要内容
临床试验/CTRI/2024/02/062607
CTRI/2024/02/062607尚未招募Phase 3 4

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

All India Institute of Medical Sciences Rishikesh1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年3月1日最近更新:

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)”. 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

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Ammapalem Satish

All India Institute of Medical Sciences, Rishikesh.

研究点 (1)

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