Critical View of Safety in Laparoscopic Cholecystectomy

Chronic Calculous Cholecystitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03696823
• Other study ID #: laparoscopic cholecystectomy
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: November 2019

Study information

• Verified date: October 2018
• Source: Assiut University
• Contact: Abanoub khalf, M.B.B.CH
• Phone: 01270127848
• Email: Abanoub.khalf[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: November 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• include all patients who will have laparoscopic cholecystectomy

Exclusion Criteria :-

• Emergency laparoscopic cholecystectomy

• Liver cirrhosis

• HCV & HBV

Related Conditions & MeSH terms

• Cholecystitis
• Chronic Calculous Cholecystitis

Intervention

Procedure:
• laparoscopic cholecystectomy
treatment of chronic calcular cholecystitis laparoscopically

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (7)

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Price NM. Electron beam therapy. Its effect on eccrine gland function in mycosis fungoides patients. Arch Dermatol. 1979 Sep;115(9):1068-70. — View Citation

Price P. Monitoring response to treatment in the development of anticancer drugs using PET. Nucl Med Biol. 2000 Oct;27(7):691. — View 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. — View 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. Japanese. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	(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').	baseline & 6 months