Critical View of Safety in Laparoscopic Cholecystectomy
Primary Purpose
Chronic Calculous Cholecystitis
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
laparoscopic cholecystectomy
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Calculous Cholecystitis
Eligibility Criteria
Inclusion Criteria:
- include all patients who will have laparoscopic cholecystectomy
Exclusion Criteria :-
- Emergency laparoscopic cholecystectomy
- Liver cirrhosis
- HCV & HBV
Sites / Locations
Outcomes
Primary Outcome Measures
(CVS) is a mean of target identification, the targets being the cystic duct and artery for changes in the incidence of biliary injury. Identifying the common bile duct as the cystic duct is the commonest cause of major bile duct injury.
Identifying the common bile duct as the cystic duct is the commonest cause of major bile duct injury.
Active identification of cystic structures within Calot's triangle is the key to a reduction in biliary injury.
To fulfil the criteria for a CVS requires Calot's triangle to be cleared free of fat and fibrous tissue ('fat cleared'), for the lowest part of the gallbladder to be dissected free from the cystic plate ('liver visible') and for there to be only two structures entering the gallbladder ('2 structures').
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03696823
Brief Title
Critical View of Safety in Laparoscopic Cholecystectomy
Official Title
Assessment of Routine Use of Critical View of Safety in Laparoscopic Cholecystectomy, Prospective Cohort Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2018 (Anticipated)
Primary Completion Date
October 2019 (Anticipated)
Study Completion Date
November 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This prospective cohort study aims to assess feasibility and safety of the approach of critical view of safety during laparoscopic cholecystectomy
Detailed Description
Since the introduction and routine use of laparoscopic cholecystectomy in the 1990s, the reported incidence of biliary injuries has doubled to 0.4%.
Many factors have been shown to influence the risk of biliary injury including patient factors (obesity, older age, male gender and adhesions), local factors (severe gallbladder inflammation/infection, aberrant anatomy and haemorrhage) as well as surgeon experience.
Identifying the common bile duct as the cystic duct is the commonest cause of major bile duct injury Active identification of cystic structures within Calot's triangle is the key to a reduction in biliary injury. Strasberg first coined the term 'critical view of safety' (CVS) in 1958 and this approach of identification of cystic structures has been adopted by many surgeons as the standard of operative technique to reduce the incidence of biliary injury.
To fulfil the criteria for a CVS requires Calot's triangle to be cleared free of fat and fibrous tissue ('fat cleared'), for the lowest part of the gallbladder to be dissected free from the cystic plate ('liver visible') and for there to be only two structures entering the gallbladder ('2 structures').
The published rate of bile duct injury with this approach is very low However more studies are needed to assess risk benefit rate of this approach.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Calculous Cholecystitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
laparoscopic cholecystectomy
Intervention Description
treatment of chronic calcular cholecystitis laparoscopically
Primary Outcome Measure Information:
Title
(CVS) is a mean of target identification, the targets being the cystic duct and artery for changes in the incidence of biliary injury. Identifying the common bile duct as the cystic duct is the commonest cause of major bile duct injury.
Description
Identifying the common bile duct as the cystic duct is the commonest cause of major bile duct injury.
Active identification of cystic structures within Calot's triangle is the key to a reduction in biliary injury.
To fulfil the criteria for a CVS requires Calot's triangle to be cleared free of fat and fibrous tissue ('fat cleared'), for the lowest part of the gallbladder to be dissected free from the cystic plate ('liver visible') and for there to be only two structures entering the gallbladder ('2 structures').
Time Frame
baseline & 6 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
include all patients who will have laparoscopic cholecystectomy
Exclusion Criteria :-
Emergency laparoscopic cholecystectomy
Liver cirrhosis
HCV & HBV
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abanoub khalf, M.B.B.CH
Phone
01270127848
Email
Abanoub.khalf@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Farouk Mourad, Professorship
Phone
01227300925
12. IPD Sharing Statement
Citations:
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986992
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Results Reference
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Critical View of Safety in Laparoscopic Cholecystectomy
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