Clinical Trials Directory

Trials / Unknown

UnknownNCT03696823

Critical View of Safety in Laparoscopic Cholecystectomy

Assessment of Routine Use of Critical View of Safety in Laparoscopic Cholecystectomy, Prospective Cohort Study

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
50 (estimated)
Sponsor
Assiut University · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDURElaparoscopic cholecystectomytreatment of chronic calcular cholecystitis laparoscopically

Timeline

Start date
2018-10-01
Primary completion
2019-10-01
Completion
2019-11-01
First posted
2018-10-05
Last updated
2018-10-05

Source: ClinicalTrials.gov record NCT03696823. Inclusion in this directory is not an endorsement.