Laparoscopic Cholecystectomy With Retro-infundibular Approach

Gallstones Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02947256
• Other study ID #: fac.med.011
• Status: Completed
• Phase: Phase 2
• First received: October 22, 2016
• Last updated: October 29, 2016
• Start date: July 2013
• Est. completion date: January 2016

Study information

• Verified date: October 2016
• Source: Minia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gallstones

Intervention

Procedure:
• standard laparoscopic cholecystectomy
which included the classic dissection of Calot's triangle to achieve the CVS, with separate clipping and division of cystic duct and artery
• RI approach
which included separation of the lower third of GB from its bed down to its pedicle (artery and duct) with mass ligation of both.

Locations

Country	Name	City	State
Egypt	Faculty of medicine	Minia
Egypt	Minia University Hospital	Minia

Sponsors (1)

Lead Sponsor	Collaborator
Minia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	conversion to open	the incidence of conversion to open	24 hours	Yes
Primary	biliary injury	the incidence of biliary injury	2 weeks	Yes
Secondary	operative time	time from skin opening to skin closure	24 hours	Yes
Secondary	hospital stay	time of hospital stay	6 weeks	Yes
Secondary	mortality	incidence of operative related mortality	6 weeks	Yes