Trial Review

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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.
Scientific title
Conventional Laparoscopic Versus Single-Incision Laparoscopic Cholecystectomy to measure postoperative pain, analgesia and cosmetic results in patients with symptomatic cholelithiasis
Secondary ID [1] 262503 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cholecystectomy 268165 0
Condition category
Condition code
Surgery 268298 268298 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 266830 0
Treatment: Surgery
Comparator / control treatment
single incision cholecystectomy
Control group
Active

Outcomes
Primary outcome [1] 269040 0
cosmotic result by self assessed questionnaires from 1 to 10
Timepoint [1] 269040 0
1st and 6th postoperative months
Secondary outcome [1] 276851 0
operative time from incision to closure in minutes
Timepoint [1] 276851 0
during the operation time in minutes from incision to closure
Secondary outcome [2] 276852 0
number of days required to return to normal activities
Timepoint [2] 276852 0
in the early postoperative period
Secondary outcome [3] 276880 0
hospital stay
Timepoint [3] 276880 0
how many days patient spent in the hospital before discharge
Secondary outcome [4] 279370 0
postoperative pain assessed by visual analogue scale from 0 to 10
Timepoint [4] 279370 0
1,2,3,4,and 5 postoperative days
Secondary outcome [5] 279371 0
requirment of analgesia and duration
Timepoint [5] 279371 0
early postoperative period

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
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelops
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)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/11/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 3670 0
Egypt
State/province [1] 3670 0

Funding & Sponsors
Funding source category [1] 267302 0
University
Name [1] 267302 0
mansoura university
Country [1] 267302 0
Egypt
Primary sponsor type
University
Name
mansoura university
Address
aljomheryah street-mansoura-dakahlia-35516
Country
Egypt
Secondary sponsor category [1] 266368 0
Hospital
Name [1] 266368 0
mansoura university hospital
Address [1] 266368 0
aljomheryah street-mansoura-dakahlia-35516
Country [1] 266368 0
Egypt

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269329 0
local health commitee
Ethics committee address [1] 269329 0
Ethics committee country [1] 269329 0
Egypt
Date submitted for ethics approval [1] 269329 0
11/09/2009
Approval date [1] 269329 0
20/10/2009
Ethics approval number [1] 269329 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32793 0
Address 32793 0
Country 32793 0
Phone 32793 0
Fax 32793 0
Email 32793 0
Contact person for public queries
Name 16040 0
mohamed elsayed abdellatif
Address 16040 0
barkelezz-mansoura-dakahlia-egypt-35516
Country 16040 0
Egypt
Phone 16040 0
+20502070665
Fax 16040 0
Email 16040 0
surg_latif@hotmail.com
Contact person for scientific queries
Name 6968 0
mohamed elsayed abdellatif
Address 6968 0
barkelezz-mansoura-dakahlia-egypt-35516
Country 6968 0
Egypt
Phone 6968 0
+20502070665
Fax 6968 0
Email 6968 0
surg_latif@hotmail.com

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.