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Critical View of Safety in Laparoscopic Cholecystectomy

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03696823
Enrollment
50
Registered
2018-10-05
Start date
2018-10-01
Completion date
2019-11-30
Last updated
2018-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Calculous Cholecystitis

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.

Interventions

PROCEDURElaparoscopic cholecystectomy

treatment of chronic calcular cholecystitis laparoscopically

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* include all patients who will have laparoscopic cholecystectomy

Exclusion criteria

:- * Emergency laparoscopic cholecystectomy * Liver cirrhosis * HCV & HBV

Design outcomes

Primary

MeasureTime frameDescription
(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 monthsIdentifying 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').

Contacts

Primary ContactAbanoub khalf, M.B.B.CH
Abanoub.khalf@yahoo.com01270127848
Backup ContactFarouk Mourad, Professorship
01227300925

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026