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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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16 December 2017 |
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Main ID: |
NCT02357589 |
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Date of registration:
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03/02/2015 |
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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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3D vs 2D HD Laparoscopy in Cholecystectomy
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Scientific title:
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3 Versus 2 Dimensional HD Laparoscopy in Cholecystectomy: a Prospective, Single Blinded, Randomized, Controlled Trial |
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Date of first enrolment:
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January 2015 |
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Target sample size:
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210 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02357589 |
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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: Treatment. Masking: Single (Participant).
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Phase:
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N/A
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Countries of recruitment
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Finland
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Contacts
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Name:
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Ville Sallinen, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Helsinki University Central Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients scheduled for laparoscopic cholecystectomy
Exclusion Criteria:
- Some other surgical operation planned during LCC
- Expected major risk of conversion (e.g. multiple previous abdominal operation,
previous peritonitis, previous cholecystitis)
- Operating surgeon experience less than 5 3D laparoscopy operations
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Cholecystolithiasis
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Intervention(s)
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Procedure: 2D laparoscopic cholecystectomy
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Procedure: 3D laparoscopic cholecystectomy
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Primary Outcome(s)
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Duration of surgery
[Time Frame: Expected average time of surgery 1 hour]
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Secondary Outcome(s)
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Mortality
[Time Frame: 30 days after randomization]
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Postoperative pain, VAS
[Time Frame: Expected range 0-7 day]
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Intraoperative complications
[Time Frame: During the operation, expected average time of surgery 1 hour]
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Postoperative stay in hospital
[Time Frame: Expected range 0-7 day]
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Need for conversion into open surgery
[Time Frame: During the operation, expected average time of surgery 1 hour]
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Bleeding
[Time Frame: During the operation, expected average time of surgery 1 hour]
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Total need of opioids in milligrams
[Time Frame: Expected range 0-7 day]
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Operation theatre time
[Time Frame: Expected average 1,5 hours]
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Complications, Clavien-Dindo classification
[Time Frame: 30 days after randomization]
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Number of participants with readmission(s)
[Time Frame: 30 days after randomization]
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Secondary ID(s)
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HUCH-328-150127
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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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