NCT03696823

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2018

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2018

Completed
11 days until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 5, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

October 5, 2018

Status Verified

October 1, 2018

Enrollment Period

1 year

First QC Date

September 20, 2018

Last Update Submit

October 3, 2018

Conditions

Chronic Calculous Cholecystitis

Outcome Measures

Primary Outcomes (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.

    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

Interventions

laparoscopic cholecystectomyPROCEDURE

treatment of chronic calcular cholecystitis laparoscopically

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • include all patients who will have laparoscopic cholecystectomy

You may not qualify if:

  • Emergency laparoscopic cholecystectomy
  • Liver cirrhosis
  • HCV \& HBV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • 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.

    PMID: 986992BACKGROUND

  • 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.

    PMID: 208213BACKGROUND

  • 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.

    PMID: 787802BACKGROUND

  • 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.

    PMID: 196202BACKGROUND

  • 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.

    PMID: 11091114BACKGROUND

  • 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.

    PMID: 114119BACKGROUND

  • 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.

    PMID: 101105BACKGROUND

MeSH Terms

Interventions

Cholecystectomy, Laparoscopic

Intervention Hierarchy (Ancestors)

CholecystectomyBiliary Tract Surgical ProceduresDigestive System Surgical ProceduresSurgical Procedures, OperativeLaparoscopyEndoscopyMinimally Invasive Surgical Procedures

Central Study Contacts

Abanoub khalf, M.B.B.CH

CONTACT

01270127848Abanoub.khalf@yahoo.com

Farouk Mourad, Professorship

CONTACT

01227300925

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

September 20, 2018

First Posted

October 5, 2018

Study Start

October 1, 2018

Primary Completion

October 1, 2019

Study Completion

November 1, 2019

Last Updated

October 5, 2018

Record last verified: 2018-10