Clinical trial NCT03696823: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Calculous Cholecystitis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-10-05
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* include all patients who will have laparoscopic cholecystectomy

Exclusion Criteria :-

* Emergency laparoscopic cholecystectomy
* Liver cirrhosis
* HCV \& HBV

Primary outcomes:
measure: (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.
timeFrame: baseline & 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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