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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03143426 |
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Date of registration:
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04/05/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Does 3D Visualisation Improve Performance of Laparoscopic Cholecystectomy by Junior Surgeons?
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Scientific title:
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Does 3D Visualisation Improve Performance of Laparoscopic Cholecystectomy by Junior Surgeons? A Randomised Controlled Trial |
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Date of first enrolment:
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April 1, 2017 |
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Target sample size:
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100 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03143426 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Participant, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Malaysia
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Contacts
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Name:
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Chan Hooi Chea, MS |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ministry of Health, Malaysia |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- All adult patients scheduled to undergo elective LC
Exclusion Criteria:
1. Patients below 18 years-old
2. Patients who declined to join the study
3. Patients with contraindications to undergo laparoscopic surgery (e.g. congestive
cardiac failure, severe respiratory disease, uncorrected coagulopathy)
4. Patients with acute cholecystitis, gallbladder neck adherent to main biliary tree or
dense omental adhesion to gallbladder
5. Patients with gallbladder tumour (suspected or confirmed)
6. Patients with variant biliary anatomy
7. Patients who had defaulted follow-up
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Conversion Laparoscopic to Open Cholecystectomy
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Complication Laparoscopic Cholecystectomy
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Intervention(s)
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Procedure: 3D laparoscopic cholecystectomy
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Primary Outcome(s)
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Complication rate
[Time Frame: 6 months]
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Secondary Outcome(s)
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Conversion to open cholecystectomy
[Time Frame: 6 months]
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Operative Time
[Time Frame: 6 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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