跳至主要内容
临床试验/CTRI/2024/05/067740
CTRI/2024/05/067740招募中Phase 3 4

Three port verses standard Four port Laparoscopic Cholecystectomy: Randomized Controlled Trial

Datta Meghe Institute of Higher Education and Research1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2024年7月25日最近更新:

试验速览

阶段
Phase 3 4
状态
招募中
发起方
入组人数
54
试验地点
1
主要终点
Comparing rates of Operative, Intra operative and postoperative complications between Three port and Four port Laparoscopic cholecystectomy

研究概览

简要总结

Gallbladder is a pear-shaped helping digestive organ located in the right upper abdomen. The functions of the gall bladder include storage, concentration, and release of bile into the intestine by simultaneous contraction of the gall bladder. Gallbladder disease is the most common digestive problem that may require hospitalization.The comprehensive review on three-port versus four-port laparoscopic cholecystectomy provides valuable insights from multiple studies, offering a nuanced understanding of the optimal approach for this common surgical procedure. The included studies consistently indicate that the three-port technique is a feasible and safe alternative to the traditional four- port method. While there may be variations in operative time, the three-port approach consistently demonstrates advantages such as reduced postoperative pain, decreased analgesic requirements, and shorter hospital stays. Notably, the three-port technique proves to be more cost-effective, contributing to a potentially quicker return to work and superior cosmetic outcomes. Surgeon experience and careful patient selection emerge as pivotal factors influencing the success of either technique. The findings underscore the importance of considering the specific clinical scenario, patient characteristics, and surgeon proficiency when choosing between the three-port and four-port laparoscopic cholecystectomy approaches. This study will be done at Acharya Vinoba Bhave Rural Hospital.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
20.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • All Cases of gallstone disease.
  • Patients undergoing prophylactic laparoscopic cholecystectomy Patients of CBD stone treated with endoscopic removal and CBD stenting.

排除标准

  • Empyema Of GB Jaundice Or Abnormal Liver Function Tests Cholangitis Portal Hypertension GB Carcinoma Enteric Fistula Patients Who Had Any Contraindications to Laparoscopic Surgery.

结局指标

主要结局

Comparing rates of Operative, Intra operative and postoperative complications between Three port and Four port Laparoscopic cholecystectomy

时间窗: Assessment will be done within 4 weeks

次要结局

  • Duration of hospitalization post-surgery.(Assessment will be done within 4 weeks)

研究者

发起方
Datta Meghe Institute of Higher Education and Research
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Subhangi Parmar

Datta Meghe Institute of Higher Education and Research

研究点 (1)

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