Laparoscopic Cholecystectomy With Retro-infundibular Approach

Sponsor

Minia University (Other)

Overall Status

Completed

CT.gov ID

NCT02947256

Collaborator

(none)

125

Enrollment

Locations

Arms

Duration (Months)

62.5

Patients Per Site

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gallstones	Procedure: standard laparoscopic cholecystectomy Procedure: RI approach	Phase 2

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 :

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

Study Design

Study Type:

Interventional

Actual Enrollment :

125 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Jul 1, 2013

Actual Primary Completion Date :

Jan 1, 2016

Actual Study Completion Date :

Jan 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: standard laparoscopic cholecystectomy This included the classic dissection of Calot's triangle to achieve the CVS, with separate clipping and division of cystic duct and artery.	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 Other Names: SLC
Experimental: RI approach 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:	Procedure: 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.

Arm

Intervention/Treatment

Active Comparator: standard laparoscopic cholecystectomy

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

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

Other Names:

SLC

Experimental: RI approach

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:

Procedure: 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.

Outcome Measures

Primary Outcome Measures

conversion to open [24 hours]
the incidence of conversion to open
biliary injury [2 weeks]
the incidence of biliary injury

Secondary Outcome Measures

operative time [24 hours]
time from skin opening to skin closure
hospital stay [6 weeks]
time of hospital stay
mortality [6 weeks]
incidence of operative related mortality

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of medicine	Minia		Egypt	61511
2	Minia University Hospital	Minia		Egypt	61511

Sponsors and Collaborators

Minia University

Investigators

Principal Investigator: Alaa M Sewefy, MD, Lecturer & consultant of general surgery, Department of surgery, Minia university hospital, Egypt.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Alaa Mstafa Hassan Sewefy, MD, Lecturer & consultant of general surgery, Department of surgery, Minia university hospital, Egypt, Minia University

ClinicalTrials.gov Identifier:

NCT02947256

Other Study ID Numbers:

fac.med.011

First Posted:

Oct 27, 2016

Last Update Posted:

Nov 1, 2016

Last Verified:

Oct 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Gallstones

Study Results

No Results Posted as of Nov 1, 2016