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Laparoscopic Cholecystectomy With Retro-infundibular Approach

Primary Purpose

Gallstones

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
standard laparoscopic cholecystectomy
RI approach
Sponsored by
Minia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gallstones

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Faculty of medicine
  • Minia University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

standard laparoscopic cholecystectomy

RI approach

Arm Description

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

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:

Outcomes

Primary Outcome Measures

conversion to open
the incidence of conversion to open
biliary injury
the incidence of biliary injury

Secondary Outcome Measures

operative time
time from skin opening to skin closure
hospital stay
time of hospital stay
mortality
incidence of operative related mortality

Full Information

First Posted
October 22, 2016
Last Updated
October 29, 2016
Sponsor
Minia University
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1. Study Identification

Unique Protocol Identification Number
NCT02947256
Brief Title
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

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minia University

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gallstones

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
125 (Actual)

8. Arms, Groups, and Interventions

Arm Title
standard laparoscopic cholecystectomy
Arm Type
Active Comparator
Arm Description
This included the classic dissection of Calot's triangle to achieve the CVS, with separate clipping and division of cystic duct and artery.
Arm Title
RI approach
Arm Type
Experimental
Arm Description
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:
Intervention Type
Procedure
Intervention Name(s)
standard laparoscopic cholecystectomy
Other Intervention Name(s)
SLC
Intervention Description
which included the classic dissection of Calot's triangle to achieve the CVS, with separate clipping and division of cystic duct and artery
Intervention Type
Procedure
Intervention Name(s)
RI approach
Intervention Description
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 Outcome Measure Information:
Title
conversion to open
Description
the incidence of conversion to open
Time Frame
24 hours
Title
biliary injury
Description
the incidence of biliary injury
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
operative time
Description
time from skin opening to skin closure
Time Frame
24 hours
Title
hospital stay
Description
time of hospital stay
Time Frame
6 weeks
Title
mortality
Description
incidence of operative related mortality
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alaa M Sewefy, MD
Organizational Affiliation
Lecturer & consultant of general surgery, Department of surgery, Minia university hospital, Egypt.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of medicine
City
Minia
ZIP/Postal Code
61511
Country
Egypt
Facility Name
Minia University Hospital
City
Minia
ZIP/Postal Code
61511
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Laparoscopic Cholecystectomy With Retro-infundibular Approach

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