Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000857808
Ethics application status
Approved
Date submitted
10/08/2012
Date registered
14/08/2012
Date last updated
14/08/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparative Study of 2D and bichanneled 3D laparoscopic image, is there a real advantage?
Scientific title
2D versus bichanneled 3D laparoscope for use in skill board models and laparoscopic cholecystectomy
outcome: image quality, surgeons' performance
Secondary ID [1] 281023 0
none
Universal Trial Number (UTN)
U1111-1132-7005
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
laparoscopic surgery 287143 0
Condition category
Condition code
Surgery 287464 287464 0 0
Surgical techniques
Public Health 287475 287475 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
comparing traditional 2D laparoscope and bichanneled 3D laparoscope in performing skill board models and laparoscopic cholecystectomy.

In skill board model, each surgeon will perform 2 tasks: knot tying and objects transfer. They will first perform object transfer using one laparoscope setting (2D or 3D, surgeon is blinded to the setting) then repeat the task using another scope setting. Then they will perform knot tying in the same manner. Both skill board model will be completed in the same session (~15-20min) on the same day

In laparoscopic cholecystectomy, each surgeon will perform 2 lap. cholecystectomy ( one with 2D scope one with 3D scope).

In both skill board model and lap. cholecystectomy model the surgeon's performance will be recorded and reviewed by an independent assessor and rate their performance. The 2 surgeries will be performed by the surgeon on separate days when the suitable cases are available

Also the surgeons will need to complete a set of questionnaire to evaluate their opinion on the 2 systems after completing the skill board and the lap. cholecystectomy
Intervention code [1] 285466 0
Treatment: Devices
Intervention code [2] 285491 0
Treatment: Surgery
Comparator / control treatment
traditional 2D laparoscope
Control group
Active

Outcomes
Primary outcome [1] 287729 0
performance in skill board model
-accuracy in grasping small objects: score 1-5, time(sec)
-accuracy in transferring small objects: score 1-5, time(sec)
-accuracy in grasping the needle and orientation: : score 1-5, time(sec)
-accuracy in needle entry and exit: score 1-5, time(sec)
-smoothness of throws and ties: score 1-5, time(sec)
Timepoint [1] 287729 0
assessment of video captured during procedure
Primary outcome [2] 287730 0
performance in lap cholecystectomy
-grasping of fundus and infundibulum: score 1-5, time(sec)
-calot's dissection: score 1-5, time(sec)
-clips application: score 1-5, time(sec)
-cystic duct transection: score 1-5, time(sec)
-dissecting gallbladder off gallbladder bed: score 1-5, time(sec)
-placement of specimen into endobag: score 1-5, time(sec)
Timepoint [2] 287730 0
assessment of video captured during procedure
Secondary outcome [1] 298728 0
opinion of operating surgeon in form of survey (score 1-10)
-Do you think 3D system improve your operation?
-Do you think 3D system is easy to handle?
-How do you rate the quality of 3D image?
-How do you rate the depth perception of the 3D image
-Do you get dizzy with 3D images?
-Do you find the 3D dual channel endoscope user-friendly?
-Do you prefer to work with 3D system in the future?
Timepoint [1] 298728 0
review immediately after procedure (skill board and lap cholecystectomy)

Eligibility
Key inclusion criteria
for lap cholecystectomy patient:
-symptomatic gallstone
-fit for GA and laparoscopic cholecystectomy
-ASA 1 or 2
-no previous abdominal surgery

for surgeon
-specialists or associate consultants in Department of Surgery, Pamela Youde Nethersole Eastern Hospital
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
for patient
-complication of gallbladder stone
-gallstone > 1cm
-contracted gallbladder/ chronic cholecystitis on ultrasound
-concurrent abdominal wall hernia
-on anticoagulant

for surgeon
-intolerance to 3D laparoscopic images
-surgeon who volunteer to withdraw from trial due to health hazard

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment outside Australia
Country [1] 4481 0
Hong Kong
State/province [1] 4481 0

Funding & Sponsors
Funding source category [1] 285792 0
Hospital
Name [1] 285792 0
Pamela Youde Nethersole Eastern Hospital
Country [1] 285792 0
Hong Kong
Primary sponsor type
Hospital
Name
Pamela Youde Nethersole Eastern Hospital
Address
3 Lok Man Road, Chai Wan, Hong Kong
Country
Hong Kong
Secondary sponsor category [1] 284615 0
None
Name [1] 284615 0
Address [1] 284615 0
Country [1] 284615 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287824 0
Ethics Committee of Hong Kong East Cluster
Ethics committee address [1] 287824 0
3 Lok Man Road, Chai Wan
Ethics committee country [1] 287824 0
Hong Kong
Date submitted for ethics approval [1] 287824 0
Approval date [1] 287824 0
Ethics approval number [1] 287824 0

Summary
Brief summary
To evaluate if there's any benefits in using the bichanneled 3D laparoscope over traditional 2D laparoscope in performing skill board tasks and laparoscopic choecystectomy
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34563 0
Address 34563 0
Country 34563 0
Phone 34563 0
Fax 34563 0
Email 34563 0
Contact person for public queries
Name 17810 0
Chan Tin Yan Christina
Address 17810 0
Pamela Youde Nethersole Eastern Hospital
3 Lok Man Road, Chai Wan, Hong Kong
Country 17810 0
Hong Kong
Phone 17810 0
+852 25956111
Fax 17810 0
Email 17810 0
[email protected]
Contact person for scientific queries
Name 8738 0
Chan Tin Yan Christina
Address 8738 0
Pamela Youde Nethersole Eastern Hospital
3 Lok Man Road, Chai Wan, Hong Kong
Country 8738 0
Hong Kong
Phone 8738 0
+852 25956111
Fax 8738 0
Email 8738 0
[email protected]

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.