Laparoscopic Cholecystectomy With Retro-infundibular Approach
1 other identifier
interventional
125
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2013
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
October 22, 2016
CompletedFirst Posted
Study publicly available on registry
October 27, 2016
CompletedNovember 1, 2016
October 1, 2016
2.5 years
October 22, 2016
October 29, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
conversion to open
the incidence of conversion to open
24 hours
biliary injury
the incidence of biliary injury
2 weeks
Secondary Outcomes (3)
operative time
24 hours
hospital stay
6 weeks
mortality
6 weeks
Study Arms (2)
standard laparoscopic cholecystectomy
ACTIVE COMPARATORThis included the classic dissection of Calot's triangle to achieve the CVS, with separate clipping and division of cystic duct and artery.
RI approach
EXPERIMENTALRetroinfundibular 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:
Interventions
which included the classic dissection of Calot's triangle to achieve the CVS, with separate clipping and division of cystic duct and artery
which included separation of the lower third of GB from its bed down to its pedicle (artery and duct) with mass ligation of both.
Eligibility Criteria
You may qualify if:
- patient with gallstones
- score difficulty according to Gupta et al 2013 \> 6
- patient fit for laparoscopic surgery
You may not qualify if:
- score difficulty according to Gupta et al 2013 \> 6
- patient unfit for laparoscopic surgery
- refusal to share in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Minia Universitylead
Study Sites (2)
Faculty of medicine
Minya, 61511, Egypt
Minia University Hospital
Minya, 61511, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alaa M Sewefy, MD
Lecturer & consultant of general surgery, Department of surgery, Minia university hospital, Egypt.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, Lecturer & consultant of general surgery, Department of surgery, Minia university hospital, Egypt
Study Record Dates
First Submitted
October 22, 2016
First Posted
October 27, 2016
Study Start
July 1, 2013
Primary Completion
January 1, 2016
Study Completion
January 1, 2016
Last Updated
November 1, 2016
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will not share