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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
Scientific title
predictor factors of technical difficulty in laparoscopic cholecystectomy: is it possible?
Secondary ID [1] 273136 0
Nil
Universal Trial Number (UTN)
U1111-1124-9587
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cholelithiathis 270891 0
Condition category
Condition code
Surgery 279066 279066 0 0
Surgical techniques
Oral and Gastrointestinal 279074 279074 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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
Intervention code [1] 269478 0
Not applicable
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)
Control group
Active

Outcomes
Primary outcome [1] 279716 0
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%.
Timepoint [1] 279716 0
at one month post operative
Secondary outcome [1] 294284 0
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
Timepoint [1] 294284 0
early operative post operative complication ( as haemorrhage , duct injury & ileus) within one month, late complications (as port site hernia) within 6 to 12 months

Eligibility
Key inclusion criteria
all cases prepared and admitted for laparoscopic cholecystectomy
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
unfit for surgery

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 3877 0
Egypt
State/province [1] 3877 0

Funding & Sponsors
Funding source category [1] 269954 0
Self funded/Unfunded
Name [1] 269954 0
Ashraf E, Abbas
Address [1] 269954 0
El-Gomhoria st, Mansoura 35516, Egypt
Country [1] 269954 0
Egypt
Funding source category [2] 269955 0
Hospital
Name [2] 269955 0
Mansoura university Hospital
Address [2] 269955 0
El-Gomhoria st, Mansoura 35516, Egypt
Country [2] 269955 0
Egypt
Primary sponsor type
Hospital
Name
Mansoura University Hospital
Address
El-Gomhoria st, Mansoura 35516, Egypt
Country
Egypt
Secondary sponsor category [1] 268951 0
Individual
Name [1] 268951 0
Ashraf E, Abbas
Address [1] 268951 0
El-Gomhoria st, Mansoura 35516 , Egypt
Country [1] 268951 0
Egypt
Other collaborator category [1] 252272 0
University
Name [1] 252272 0
Mansoura University
Address [1] 252272 0
El-Gomhoria st, Mansoura 35516, Egypt
Country [1] 252272 0
Egypt

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271924 0
local departmental ethical committee
Ethics committee address [1] 271924 0
El-Gomhoria st, Mansoura 35516, Egypt, Surgery department
Ethics committee country [1] 271924 0
Egypt
Date submitted for ethics approval [1] 271924 0
Approval date [1] 271924 0
01/05/2008
Ethics approval number [1] 271924 0
Ethics committee name [2] 271956 0
Mansoura Medical research Ethics committee
Ethics committee address [2] 271956 0
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
Ethics committee country [2] 271956 0
Egypt
Date submitted for ethics approval [2] 271956 0
Approval date [2] 271956 0
01/10/2011
Ethics approval number [2] 271956 0

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
Trial website
Trial related presentations / publications
nil
Public notes

Contacts
Principal investigator
Name 33219 0
Address 33219 0
Country 33219 0
Phone 33219 0
Fax 33219 0
Email 33219 0
Contact person for public queries
Name 16466 0
Ashraf El-Sayed Abbas
Address 16466 0
El-Gomhoria st, Mansoura 35516, Egypt
Country 16466 0
Egypt
Phone 16466 0
+20184777248
Fax 16466 0
+20502267016
Email 16466 0
ashrafabbaas@hotmail.com
Contact person for scientific queries
Name 7394 0
Ashraf El-Sayed Abbas
Address 7394 0
El-Gomhoria st, Mansoura 35516, Egypt
Country 7394 0
Egypt
Phone 7394 0
+20184777248
Fax 7394 0
+20502267016
Email 7394 0
ashrafabbaas@hotmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary