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Trial registered on ANZCTR
Registration number
ACTRN12611000670976
Ethics application status
Approved
Date submitted
24/06/2011
Date registered
4/07/2011
Date last updated
24/02/2012
Type of registration
Retrospectively registered
Titles & IDs
Public title
Quality of life measures after single access Vs Conventional Laparoscopic Cholecystectomy: Prospective Randomized Study.
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Scientific title
Conventional Laparoscopic Versus Single-Incision Laparoscopic Cholecystectomy to measure postoperative pain, analgesia and cosmetic results in patients with symptomatic cholelithiasis
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Secondary ID [1]
262503
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none
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Universal Trial Number (UTN)
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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:
cholecystectomy
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Condition category
Condition code
Surgery
268298
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0
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Surgical techniques
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
single incision cholecystectomy versus conventional cholecystectomy over 50 patients 25 each, the 1st group patients included 25 cases and laparoscopic cholecystectomy was done for them using single transumblical incision while the 2nd group included 25 cases and standard 4 ports cholecystectomy was done for them
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Intervention code [1]
266830
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Treatment: Surgery
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Comparator / control treatment
single incision cholecystectomy
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Control group
Active
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Outcomes
Primary outcome [1]
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cosmotic result by self assessed questionnaires from 1 to 10
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Assessment method [1]
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Timepoint [1]
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1st and 6th postoperative months
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Secondary outcome [1]
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operative time from incision to closure in minutes
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Assessment method [1]
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Timepoint [1]
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during the operation time in minutes from incision to closure
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Secondary outcome [2]
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number of days required to return to normal activities
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Assessment method [2]
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Timepoint [2]
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in the early postoperative period
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Secondary outcome [3]
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hospital stay
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Assessment method [3]
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Timepoint [3]
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how many days patient spent in the hospital before discharge
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Secondary outcome [4]
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postoperative pain assessed by visual analogue scale from 0 to 10
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Assessment method [4]
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Timepoint [4]
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1,2,3,4,and 5 postoperative days
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Secondary outcome [5]
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requirment of analgesia and duration
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Assessment method [5]
279371
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Timepoint [5]
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early postoperative period
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Eligibility
Key inclusion criteria
All patients with symptomatic cholelithiasis verified by abdominal ultrasonography, who were scheduled for elective cholecystectomy and were fit for general anaesthesia
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Minimum age
18
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
acute cholecystitis, abnormal liver function tests, those found to have a contracted or thickened gallbladder on the ultrasound examination, BMI above 35 kg/m2, whose American Society of Anesthesiologists classification above 3 and those with previous laparotomy
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelops
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomization by using a randomization table created by computer software dividing the total nomber into 2 groups either single incision laparoscopic cholecystectomy (1st group) and conventional laparoscopic cholecystectomy (2nd group)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety
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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
6/11/2009
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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
50
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
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Egypt
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State/province [1]
3670
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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mansoura university
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Address [1]
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aljomheryah street-mansoura-dakahlia-35516
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Country [1]
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Egypt
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Primary sponsor type
University
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Name
mansoura university
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Address
aljomheryah street-mansoura-dakahlia-35516
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Country
Egypt
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Secondary sponsor category [1]
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Hospital
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Name [1]
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mansoura university hospital
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Address [1]
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aljomheryah street-mansoura-dakahlia-35516
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Country [1]
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Egypt
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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local health commitee
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Ethics committee address [1]
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aljomheryah street-mansoura-dakahlia-35516 (department of surgery)
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Ethics committee country [1]
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Egypt
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Date submitted for ethics approval [1]
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11/09/2009
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Approval date [1]
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20/10/2009
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Ethics approval number [1]
269329
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Summary
Brief summary
it is suggested that single incision cholecystectomy is safe and feasible alternative to conventional laparoscopic cholecystectomy . we conducted this study prospectively in a randomized way to prove such benifits
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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mohamed elsayed abdellatif
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Address
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barkelezz-mansoura-dakahlia-egypt-35516
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Country
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Egypt
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Phone
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+20502070665
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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mohamed elsayed abdellatif
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Address
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barkelezz-mansoura-dakahlia-egypt-35516
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Country
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Egypt
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Phone
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+20502070665
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Fax
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Email
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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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