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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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6 October 2015 |
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Main ID: |
NCT01397565 |
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Date of registration:
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05/07/2011 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Minilaparoscopic Versus Conventional Laparoscopic Cholecystectomy
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Scientific title:
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Minilaparoscopic Versus Conventional Laparoscopic Cholecystectomy: A Randomized Trial |
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Date of first enrolment:
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February 2012 |
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Target sample size:
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115 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01397565 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Canada
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Contacts
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Name:
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Liane Feldman, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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McGill University Health Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- minimum 18 years of age
- referred for elective cholecystectomy for benign biliary stone disease
Exclusion Criteria:
- previous upper gastrointestinal surgery
- acute cholecystitis (past or present)
- American Society of Anesthesiologists (ASA) class greater than or equal to 4
- pregnancy
- morbid obesity (BMI > 35 kg/m2)
- inability to comprehend questionnaires in either English or French
- psychiatric conditions that preclude cooperation and/or comprehension of
questionnaires
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cholelithiasis
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Cholecystectomy
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Intervention(s)
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Procedure: Laparoscopic cholecystectomy
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Procedure: Minilaparoscopic cholecystectomy
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Primary Outcome(s)
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Post-operative pain
[Time Frame: First seven days post-op, 3 weeks post-op]
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Time to recovery
[Time Frame: 3 weeks post-operatively]
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Cosmetic result
[Time Frame: 3 months post-operatively]
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Secondary Outcome(s)
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Operative complications
[Time Frame: First 3 months post-op]
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Length of operation
[Time Frame: Recorded at visit 3 weeks post-op]
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Operative technique
[Time Frame: Recorded at visit 3 weeks post-op]
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Secondary ID(s)
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11-053-SDR
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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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