跳至主要内容
临床试验/CTRI/2025/08/092214
CTRI/2025/08/092214招募中不适用

A comparative study of gall bladder extraction techniques in Laparoscopic Cholecystectomy- Umbilical port v/s Epigastric port

Dr Pranay Shukla1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2025年8月1日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
84
试验地点
1
主要终点
To compare post operative pain at extraction site using VAS score between the two techniques of gallbladdder extraction techniques.

研究概览

简要总结

The procedure for this study involves enrolling patients scheduled for elective laparoscopic cholecystectomy who meet the inclusion criteria. After obtaining informed preoperative consent, standard laparoscopic cholecystectomy is performed wherein the gallbladder is dissected and placed in an endobag for retrieval. Depending on the surgeon’s preference, the gallbladder is extracted either through the umbilical port or the epigastric port—both of which are standard 10 mm working ports used in the surgery.No randomization is involved, and patients are grouped based on the port used for extraction. Postoperative pain is managed uniformly with intravenous paracetamol 1 gram every 8 hours. Pain scores are assessed using the Visual Analog Scale (VAS) on postoperative day 1, during the first follow-up visit, and again at 3 months via telephone. Additional parameters recorded include the duration of the retrieval process, surgical site infection rates at the extraction port, postoperative hospital stay, and development of port-site hernia at 3 months. Data is collected in a standardized pro forma and subjected to statistical analysis to determine the significance of differences between the two extraction techniques.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • All patients with symptomatic gall stone disease or previously treated acute cholecystitis planned for interval laparoscopic cholecystectomy.

排除标准

  • Age less than 18 yrs.
  • Emergency laparoscopic cholecystectomy (Acute cholecystitis, empyema or gangrenous gallbladder.) -Suspected or confirmed gall bladder carcinoma -Conversion to open -Retrieval done without using endo bag -Other laparoscopic surgeries done along with laparoscopic cholecystectomy -History of laparoscopic surgeries in the past with umbilical or epigastric ports .
  • Laparoscopic cholecystectomy done without using two 10mm ports.
  • Diagnosed case of umbilical hernia with primary repair done during laparoscopic cholecystectomy.
  • Perioperative TAP block for port site.

结局指标

主要结局

To compare post operative pain at extraction site using VAS score between the two techniques of gallbladdder extraction techniques.

时间窗: POD 1, 1st follow up and 3months after surgery.

次要结局

  • To compare outcomes of extraction techniques in laparoscopic cholecystectomy in terms of SSI, postoperative stay, and incidences of port site hernia.(POD 1, 1st follow up and 3 months after surgery.)

研究者

发起方
Dr Pranay Shukla
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Pranay Shukla

Kasturba hospital, Manipal

研究点 (1)

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