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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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29 April 2024 |
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Main ID: |
NCT03014817 |
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Date of registration:
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05/01/2017 |
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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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Ultrasonically Activated Scalpel Versus Electrocautery Based Dissection in Acute Cholecystitis Trial
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Scientific title:
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Ultrasonically Activated Scalpel Versus Electrocautery Based Dissection in Acute Cholecystitis. A Randomized, Double Blind, Multicenter Study |
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Date of first enrolment:
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October 1, 2019 |
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Target sample size:
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180 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT03014817 |
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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: 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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Sweden
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Contacts
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Name:
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Gabriel Sandblom, Assoc Prof |
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Address:
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Telephone:
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Email:
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Affiliation:
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Karolinska Institutet |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Emergency laparoscopic cholecystectomy performed for cholecystitis
- American Society of Anesthesiologists (ASA) score I-III
Exclusion Criteria:
- Patients unable to express themselves in Swedish
- Pregnancy
- Previous open surgery in the upper abdomen
- American Society of Anesthesiologists (ASA) score >III
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Cholecystitis, Acute
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Intervention(s)
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Procedure: Electrocautery
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Procedure: Ultrasonically activated scalpel
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Primary Outcome(s)
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Postoperative complications
[Time Frame: 30 days]
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Secondary Outcome(s)
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Technical performance
[Time Frame: 3 hours]
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Direct and indirect medical costs
[Time Frame: 30 days]
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Postoperative stay
[Time Frame: 14 days]
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Level of technical complexity
[Time Frame: 3 hours]
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Postoperative pain
[Time Frame: 7 days]
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Conversion rate
[Time Frame: 3 hours]
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Sick leave
[Time Frame: 30 days]
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Operative time
[Time Frame: 3 hours]
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Postoperative inflammatory activity
[Time Frame: 7 days]
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Secondary ID(s)
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Ultrasonic scalpel trial
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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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