Comparing Minilaparotomy and Laparoscopic Cholecystectomy as a Day Surgery Procedure
Not Applicable
Completed
- Conditions
- Gallstone Disease
- Interventions
- Procedure: Cholecystectomy
- Registration Number
- NCT01873638
- Lead Sponsor
- Kuopio University Hospital
- Brief Summary
Minlaparotomy (MC) and laparoscopic cholecystoctomy (LC) are commonly applied surgical techniques for the management of symptomatic gallstone disease and both techiques have shown to be feasible for day surgery. However, to our knowledge the long-term outcome between these approaches has not been compared in randomised trials as day surgery procedures.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
- Cholelithiasis confirmed by preoperative ulrasound
- No significant co-morbidities
- The ASA physical status classification 1 or 2
- Age 18 to 65 yrs.
- BMI less than 35
- Less than a one hour journey from hospital to home
- Patient´s own motivation to daysurgery
Exclusion Criteria
- Elevated liver laboratory tests
- Earlier jaundice
- A suspicion or verified stones in the common bile duct
- Acute cholecystitis
- A history of pancreatitis
- Hepatic cirrhosis
- Suspicion of cancer
- Previous open upper abdominal surgery
- Asthma
- Peptic ulcer
- Bleeding disorders
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Minilaparotomy Cholecystectomy Minilaparotomy cholecystectomy as a day surgery Laparoscopy Cholecystectomy Laparoscopic cholecystectomy as a day surgery
- Primary Outcome Measures
Name Time Method Chronic post-surgical pain Five year outcome
- Secondary Outcome Measures
Name Time Method Quality of life Five year outcome
Trial Locations
- Locations (1)
Kuopio University Hospital
🇫🇮Kuopio, Northern Savo, Finland