Critical View of Safety in Laparoscopic Cholecystectomy

Not Applicable

• Conditions: Chronic Calculous Cholecystitis

• Registration Number: NCT03696823
• Lead Sponsor: Assiut University

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.

Study Timeline

• Study First Submitted: 2018-09-20
• Status Verified: 2018-10
• Study Start: 2018-10-01
• Study First Submitted QC: 2018-10-03
• Last Update Submitted: 2018-10-03
• Study First Posted: 2018-10-05
• Last Update Posted: 2018-10-05
• Primary Completion: 2019-10
• Study Completion: 2019-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• include all patients who will have laparoscopic cholecystectomy

Exclusion Criteria :-

• Emergency laparoscopic cholecystectomy
• Liver cirrhosis
• HCV & HBV

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
(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.	baseline & 6 months	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').