Critical View of Safety in Laparoscopic Cholecystectomy

NCT ID: NCT03696823

Last Updated: 2018-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2019-11-30

Brief Summary

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This prospective cohort study aims to assess feasibility and safety of the approach of critical view of safety during laparoscopic cholecystectomy

Detailed Description

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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

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Chronic Calculous Cholecystitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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laparoscopic cholecystectomy

treatment of chronic calcular cholecystitis laparoscopically

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* include all patients who will have laparoscopic cholecystectomy

Exclusion Criteria

* Emergency laparoscopic cholecystectomy
* Liver cirrhosis
* HCV \& HBV
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Abanoub Khalf Henry Romany

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Abanoub khalf, M.B.B.CH

Role: CONTACT

01270127848

Farouk Mourad, Professorship

Role: CONTACT

01227300925

References

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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.

Reference Type BACKGROUND
PMID: 986992 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 208213 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 787802 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 196202 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11091114 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 114119 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 101105 (View on PubMed)

Other Identifiers

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laparoscopic cholecystectomy

Identifier Type: -

Identifier Source: org_study_id

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