Critical View of Safety in Laparoscopic Cholecystectomy

Sponsor
Assiut University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03696823
Collaborator
(none)
50
13

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: laparoscopic cholecystectomy
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Assessment of Routine Use of Critical View of Safety in Laparoscopic Cholecystectomy, Prospective Cohort Study
Anticipated Study Start Date :
Oct 1, 2018
Anticipated Primary Completion Date :
Oct 1, 2019
Anticipated Study Completion Date :
Nov 1, 2019

Outcome Measures

Primary Outcome Measures

  1. (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').

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • include all patients who will have laparoscopic cholecystectomy

Exclusion Criteria :-

  • Emergency laparoscopic cholecystectomy

  • Liver cirrhosis

  • HCV & HBV

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Abanoub Khalf Henry Romany, principal investigator, Assiut University
ClinicalTrials.gov Identifier:
NCT03696823
Other Study ID Numbers:
  • laparoscopic cholecystectomy
First Posted:
Oct 5, 2018
Last Update Posted:
Oct 5, 2018
Last Verified:
Oct 1, 2018
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 5, 2018