Clinical trial NCT02947256: Laparoscopic Cholecystectomy With Retro-infundibular Approach
Official title: Laparoscopic Cholecystectomy With Retro-infundibular Approach Versus Standard Laparoscopic Cholecystectomy in Difficult Cases, Where Calot's Triangle is Unsafe to be Dissected
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gallstones
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2016-10-27
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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

Eligibility criteria: 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

Primary outcomes:
measure: conversion to open
timeFrame: 24 hours
measure: biliary injury
timeFrame: 2 weeks
Secondary outcomes:
measure: operative time
timeFrame: 24 hours
measure: hospital stay
timeFrame: 6 weeks
measure: mortality
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Minia
country: Egypt
facility: Faculty of medicine
city: Minia
country: Egypt
facility: Minia University Hospital
Study officials:
affiliation: Lecturer & consultant of general surgery, Department of surgery, Minia university hospital, Egypt.
name: Alaa M Sewefy, MD
role: PRINCIPAL_INVESTIGATOR
References: