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Critical View of Safety in Laparoscopic Cholecystectomy

Primary Purpose

Chronic Calculous Cholecystitis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
laparoscopic cholecystectomy
Sponsored by
Assiut University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Calculous Cholecystitis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • include all patients who will have laparoscopic cholecystectomy

Exclusion Criteria :-

  • Emergency laparoscopic cholecystectomy
  • Liver cirrhosis
  • HCV & HBV

Sites / Locations

    Outcomes

    Primary Outcome Measures

    (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.
    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').

    Secondary Outcome Measures

    Full Information

    First Posted
    September 20, 2018
    Last Updated
    October 3, 2018
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03696823
    Brief Title
    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

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 1, 2018 (Anticipated)
    Primary Completion Date
    October 2019 (Anticipated)
    Study Completion Date
    November 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

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

    5. 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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Calculous Cholecystitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Procedure
    Intervention Name(s)
    laparoscopic cholecystectomy
    Intervention Description
    treatment of chronic calcular cholecystitis laparoscopically
    Primary Outcome Measure Information:
    Title
    (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.
    Description
    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').
    Time Frame
    baseline & 6 months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: include all patients who will have laparoscopic cholecystectomy Exclusion Criteria :- Emergency laparoscopic cholecystectomy Liver cirrhosis HCV & HBV
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Abanoub khalf, M.B.B.CH
    Phone
    01270127848
    Email
    Abanoub.khalf@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Farouk Mourad, Professorship
    Phone
    01227300925

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    986992
    Citation
    Yamazaki M, Ikeda Y, Ishikawa M, Inagaki C, Tanaka C. [Inhibition of harmaline induced tremor by L-threo-3, 4-dihydroxyphenylserine, an L-norepinephrine precursor]. Nihon Yakurigaku Zasshi. 1976 Apr;72(3):363-9. doi: 10.1254/fpj.72.363. Japanese.
    Results Reference
    background
    PubMed Identifier
    208213
    Citation
    Rohner TJ, Hannigan JD, Sanford EJ. Altered in vitro adrenergic responses of dog detrusor msucle after chronic bladder outlet obstruction. Urology. 1978 Apr;11(4):357-61. doi: 10.1016/0090-4295(78)90231-5.
    Results Reference
    background
    PubMed Identifier
    787802
    Citation
    Hoffmann MK, Green S, Old LJ, Oettgen HF. Serum containing endotoxin-induced tumour necrosis factor substitutes for helper T cells. Nature. 1976 Sep 30;263(5576):416-7. doi: 10.1038/263416a0. No abstract available.
    Results Reference
    background
    PubMed Identifier
    196202
    Citation
    Ditta G, Soderberg K, Scheffler IE. Chinese hamster cell mutant with defective mitochondrial protein synthesis. Nature. 1977 Jul 7;268(5615):64-7. doi: 10.1038/268064a0. No abstract available.
    Results Reference
    background
    PubMed Identifier
    11091114
    Citation
    Price P. Monitoring response to treatment in the development of anticancer drugs using PET. Nucl Med Biol. 2000 Oct;27(7):691. doi: 10.1016/s0969-8051(00)00140-2. No abstract available.
    Results Reference
    background
    PubMed Identifier
    114119
    Citation
    Price NM. Electron beam therapy. Its effect on eccrine gland function in mycosis fungoides patients. Arch Dermatol. 1979 Sep;115(9):1068-70. doi: 10.1001/archderm.115.9.1068.
    Results Reference
    background
    PubMed Identifier
    101105
    Citation
    Carp H, Janoff A. Possible mechanisms of emphysema in smokers. In vitro suppression of serum elastase-inhibitory capacity by fresh cigarette smoke and its prevention by antioxidants. Am Rev Respir Dis. 1978 Sep;118(3):617-21. doi: 10.1164/arrd.1978.118.3.617.
    Results Reference
    background

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    Critical View of Safety in Laparoscopic Cholecystectomy

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