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临床试验/NCT02947256
NCT02947256已完成2 期

Laparoscopic Cholecystectomy With Retro-infundibular Approach Versus Standard Laparoscopic Cholecystectomy in Difficult Cases, Where Calot's Triangle is Unsafe to be Dissected

Minia University2 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2013年7月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
125
试验地点
2
主要终点
conversion to open

研究概览

简要总结

Aimed to evaluate laparoscopic cholecystectomy by retro-infundibular (RI) approach compared to standard laparoscopic cholecystectomy (SLC) in difficult cases with scarred chole-cystohepatic (Calot's) triangle.

详细描述

This study is a prospective cohort study, conducted in Minia university hospital and Minia insurance hospital in the period from July 2013 to January 2016, where 597 patients with gallstones were admitted for laparoscopic cholecystectomy and were done by the same surgeon. Based on the preoperative scoring system to predict the degree of difficulty in laparoscopic cholecystectomy, patients that had the score > 6 and were fit for laparoscopic surgery were included in the study. Only 125 met these criteria and agreed to share in the study and gave their informed consent. 60 patients were operated by SLC (Group 1).This included the classic dissection of Calot's triangle to achieve the CVS, with separate clipping and division of cystic duct and artery. While, 65 patients were operated by laparoscopic cholecystectomy using RI approach (Group 2). This included separation of the lower third of GB from its bed down to its pedicle (artery and duct) with mass ligation of both.

Operative procedure of by RI approach:

The site of trocars was the same as for the standard cholecystectomy. After dissection of adhesion masking the GB, if present, to reach the Hartmann pouch, at this point Calot's triangle usually was scarred and frozen, the surgeon never tried to dissect it and instead the surgeon continued as follow :

  1. De-shouldering of GB: by incising the serosal covering on either side of the infundibulum and lower part of the body.
  2. This followed by dissection and separation of the lower third of GB body from its bed, using suction-irrigation probe or hook dissector. Dissection continued downward till the GB pedicle (duct and artery).
  3. Mass ligation of cystic artery and duct, using intracorporeal note by vicryl number 1 suture.
  4. Then the surgeon cut above the ligature using diathermy on scissor or ultrasound sealing device. During this step the cut end of the GB was grasped by forceps trying to prevent spillage of its content, if happened, stones were collected in a bag and extracted.
  5. Then GB was dissected from its bed as usual and extracted in a bag. In cases where the GB was hugely distended, it was aspirated firstly to facilitate its grasping. Also in cases of Mirizzi syndrome the GB was opened direct on the stone to remove it, to facilitate grasping of GB then we continued as described above

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •patient with gallstones
  • •score difficulty according to Gupta et al 2013 > 6
  • •patient fit for laparoscopic surgery

排除标准

  • •score difficulty according to Gupta et al 2013 > 6
  • •patient unfit for laparoscopic surgery
  • •refusal to share in the study

研究组 & 干预措施

standard laparoscopic cholecystectomy

Active Comparator

This included the classic dissection of Calot's triangle to achieve the CVS, with separate clipping and division of cystic duct and artery.

干预措施: standard laparoscopic cholecystectomy (Procedure)

RI approach

Experimental

Retroinfundibular laparoscopic cholecystectomy: This included separation of the lower third of GB from its bed down to its pedicle (artery and duct) with mass ligation of both.

Operative procedure of by RI approach:

干预措施: RI approach (Procedure)

结局指标

主要结局

conversion to open

时间窗: 24 hours

the incidence of conversion to open

biliary injury

时间窗: 2 weeks

the incidence of biliary injury

次要结局

  • operative time(24 hours)
  • hospital stay(6 weeks)
  • mortality(6 weeks)

研究者

发起方
Minia University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alaa Mstafa Hassan Sewefy

MD, Lecturer & consultant of general surgery, Department of surgery, Minia university hospital, Egypt

Minia University

研究点 (2)

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