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Trial registered on ANZCTR
Registration number
ACTRN12611001054909
Ethics application status
Approved
Date submitted
30/09/2011
Date registered
10/10/2011
Date last updated
10/10/2011
Type of registration
Retrospectively registered
Titles & IDs
Public title
predictor factors of technical difficulty in laparoscopic cholecystectomy
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Scientific title
predictor factors of technical difficulty in laparoscopic cholecystectomy: is it possible?
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Secondary ID [1]
273136
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Nil
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Universal Trial Number (UTN)
U1111-1124-9587
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
cholelithiathis
270891
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Condition category
Condition code
Surgery
279066
279066
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0
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Surgical techniques
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Oral and Gastrointestinal
279074
279074
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Laparoscopic cholecystectomy procedure, the outcome of 500 consecutive cases were observed for (operative, post operative complications, long time procedure, or long hospital stay) & divided accordingly to 2 groups complicated and non complicated and the pre-operative variables (e.g history, U.S, or laboratory) will be tested for significant statistical analysis
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Intervention code [1]
269478
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Not applicable
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Comparator / control treatment
uncomplicated cases, versus the complicated cases (operative & short post -operative complications, long procedure, long hospital stay) over the early post operative course ( one month)
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Control group
Active
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Outcomes
Primary outcome [1]
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1- is to define the pre - operative risk factors of a difficult procedure of laparoscopic cholecystectomy. i.e (difficult procedure means complicated cases , long hospital stay, or long procedure). Early operative post operative complication ( as haemorrhage , duct injury & ileus, etc)
The cases are classified into two groups complicated and Non complicated group according to patient's sheet of preoperative operative and post operative sheet including follow up sheet, using clinical examination and assessment or radiological or endoscopic intervention when needed data entry and analysis was done using SPSS V 17, quantitative data of variables well be represented as means an SD, T test will be used to compare between means of two groups,qualitative data well be presented as numbers and percentage and compared using the Chi square test. Odds ratio and 95% confidence interval well be used to assess the risk of developing complications in relation to the studied variables. All factors proved significant association with complications by crude analysis well be entered into binary logistic regression variation analysis to determine the independent predictors of complications. P is significant if equal or less than 0.05 at confidence interval 95%.
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Assessment method [1]
279716
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Timepoint [1]
279716
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at one month post operative
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Secondary outcome [1]
294284
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secondary outcome is the morbidity of the procedure
over all complication rate, and single complication incidence and rate as numbers and percentage from the total sample
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Assessment method [1]
294284
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Timepoint [1]
294284
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early operative post operative complication ( as haemorrhage , duct injury & ileus) within one month, late complications (as port site hernia) within 6 to 12 months
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Eligibility
Key inclusion criteria
all cases prepared and admitted for laparoscopic cholecystectomy
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
unfit for surgery
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Study design
Purpose
Screening
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Duration
Longitudinal
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Selection
Defined population
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Timing
Retrospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/01/2011
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
500
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
3877
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Egypt
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State/province [1]
3877
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Funding & Sponsors
Funding source category [1]
269954
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Self funded/Unfunded
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Name [1]
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Ashraf E, Abbas
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Address [1]
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El-Gomhoria st, Mansoura 35516, Egypt
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Country [1]
269954
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Egypt
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Funding source category [2]
269955
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Hospital
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Name [2]
269955
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Mansoura university Hospital
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Address [2]
269955
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El-Gomhoria st, Mansoura 35516, Egypt
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Country [2]
269955
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Egypt
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Primary sponsor type
Hospital
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Name
Mansoura University Hospital
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Address
El-Gomhoria st, Mansoura 35516, Egypt
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Country
Egypt
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Secondary sponsor category [1]
268951
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Individual
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Name [1]
268951
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Ashraf E, Abbas
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Address [1]
268951
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El-Gomhoria st, Mansoura 35516 , Egypt
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Country [1]
268951
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Egypt
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Other collaborator category [1]
252272
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University
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Name [1]
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Mansoura University
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Address [1]
252272
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El-Gomhoria st, Mansoura 35516, Egypt
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Country [1]
252272
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Egypt
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
271924
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local departmental ethical committee
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Ethics committee address [1]
271924
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El-Gomhoria st, Mansoura 35516, Egypt, Surgery department
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Ethics committee country [1]
271924
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Egypt
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Date submitted for ethics approval [1]
271924
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Approval date [1]
271924
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01/05/2008
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Ethics approval number [1]
271924
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Ethics committee name [2]
271956
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Mansoura Medical research Ethics committee
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Ethics committee address [2]
271956
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El-Gomhoria st, Mansoura 35516, Egypt,
trial was approved via local departmental ethical committee at 1/05/2008 then re-entered to the main committee in faculty of medicine
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Ethics committee country [2]
271956
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Egypt
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Date submitted for ethics approval [2]
271956
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Approval date [2]
271956
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01/10/2011
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Ethics approval number [2]
271956
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Summary
Brief summary
The aim of the study is to evaluate the risk factors that may reflect a technical difficulties of the popular procedure like laparscopic cholecystectomy, through identification of the complicated cases (Long procedure, conversion, early complications, or long hospital stay) and to compare with uncomplicated cases reaching may be to a score of difficulty, which may be used for surgical trainee or resident programs
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Trial website
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Trial related presentations / publications
nil
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Public notes
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Contacts
Principal investigator
Name
33219
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Address
33219
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Country
33219
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Phone
33219
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Fax
33219
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Email
33219
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Contact person for public queries
Name
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Ashraf El-Sayed Abbas
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Address
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El-Gomhoria st, Mansoura 35516, Egypt
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Country
16466
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Egypt
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Phone
16466
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+20184777248
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Fax
16466
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+20502267016
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Email
16466
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[email protected]
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Contact person for scientific queries
Name
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Ashraf El-Sayed Abbas
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Address
7394
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El-Gomhoria st, Mansoura 35516, Egypt
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Country
7394
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Egypt
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Phone
7394
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+20184777248
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Fax
7394
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+20502267016
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Email
7394
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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