Gallstone Disease
Conditions
Keywords
5-year outcome after cholecystectomy
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.
Interventions
PROCEDURECholecystectomy
Sponsors
Kuopio University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Chronic post-surgical pain | Five year outcome |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life | Five year outcome |
Other
| Measure | Time frame |
|---|---|
| Cosmetic satisfaction | Five year outcome |
| Residual abdominal symptoms | Five year outcome |
Countries
Finland
Outcome results
None listed