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Critical View of Safety in Laparoscopic Cholecystectomy

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ClinicalTrials.gov Identifier: NCT03696823
Recruitment Status : Not yet recruiting
First Posted : October 5, 2018
Last Update Posted : October 5, 2018
Sponsor:
Information provided by (Responsible Party):
Abanoub Khalf Henry Romany, 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

Condition or disease Intervention/treatment Phase
Chronic Calculous Cholecystitis Procedure: laparoscopic cholecystectomy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
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
Estimated Study Start Date : October 1, 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • Procedure: laparoscopic cholecystectomy
    treatment of chronic calcular cholecystitis laparoscopically


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. [ Time Frame: 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').




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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • include all patients who will have laparoscopic cholecystectomy

Exclusion Criteria :-

  • Emergency laparoscopic cholecystectomy
  • Liver cirrhosis
  • HCV & HBV

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03696823


Contacts
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Contact: Abanoub khalf, M.B.B.CH 01270127848 Abanoub.khalf@yahoo.com
Contact: Farouk Mourad, Professorship 01227300925

Sponsors and Collaborators
Assiut University

Publications:
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Responsible Party: Abanoub Khalf Henry Romany, principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03696823     History of Changes
Other Study ID Numbers: laparoscopic cholecystectomy
First Posted: October 5, 2018    Key Record Dates
Last Update Posted: October 5, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Cholecystitis
Acalculous Cholecystitis
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases