NCT01553331CompletedNot Applicable
Day Case Laparoscopic Cholecystectomy: Comparison of Fundus First With Ultrasonic Dissection or Conventional Diathermy Hook, Randomized Trial
Central Finland Hospital District2 sites in 1 country169 target enrollmentStarted: March 1, 2012Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 169
- Locations
- 2
- Primary Endpoint
- same day discharge
Study Overview
Brief Summary
Day case laparoscopic cholecystectomy can be made with conventional diathermy hook starting at triangle of Calot´s. Ultrasonic dissection starting from the gallbladder fundus is another option. The aim is to test the hypothesis that with ultrasonic dissection technique a better same day discharge and a shorter operative time can be achieved.
Detailed Description
After initiation of general anesthesia patients are randomized either to conventional or ultrasonic dissection group. The patients and recovery room personnel are blinded to the operative technique used.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •BMI under 35
- •normal liver enzymes
- •no bile duct dilatation in ultrasound
- •cholecystolithiasis
Exclusion Criteria
- •NSAID allergy
- •previous upper gi-surgery
- •common bile duct stones in preoperative imaging
- •history of severe acute pancreatitis
Outcomes
Primary Outcomes
same day discharge
Time Frame: 30 days
operative time
Time Frame: 30 days
intraoperative complications
Time Frame: 30 days
Secondary Outcomes
- analgetic use(30 days)
- postoperative nausea and vomiting(30 days)
- readmission(30 days)
- morbidity(30 days)
Investigators
Anne Mattila
MD
Central Finland Hospital District
Study Sites (2)
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