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Completed

NCT Number: NCT02947256

Laparoscopic Cholecystectomy With Retro-infundibular Approach

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Faculty of medicine, Minya, Egypt

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About this study

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 :

  • De-shouldering of GB: by incising the serosal covering on either side of the infundibulum and lower part of the body.
  • 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).
  • Mass ligation of cystic artery and duct, using intracorporeal note by vicryl number 1 suture.
  • 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.
  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Standard Laparoscopic Cholecystectomy

Procedure

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

Other names: SLC

RI approach

Procedure

which included separation of the lower third of GB from its bed down to its pedicle (artery and duct) with mass ligation of both.

Primary outcomes

  1. conversion to open

    Time frame: 24 hours

    the incidence of conversion to open

  2. biliary injury

    Time frame: 2 weeks

    the incidence of biliary injury

Secondary outcomes

  1. operative time

    Time frame: 24 hours

    time from skin opening to skin closure

  2. hospital stay

    Time frame: 6 weeks

    time of hospital stay

  3. mortality

    Time frame: 6 weeks

    incidence of operative related mortality

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Oct 27, 2016
Registry last updated
Nov 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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