Gallstone Disease Clinical Trial
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | April 2008 |
Est. primary completion date | April 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Finland | Kuopio University Hospital | Kuopio | Northern Savo |
Lead Sponsor | Collaborator |
---|---|
Kuopio University Hospital |
Finland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Cosmetic satisfaction | Five year outcome | Yes | |
Other | Residual abdominal symptoms | Five year outcome | Yes | |
Primary | Chronic post-surgical pain | Five year outcome | Yes | |
Secondary | Quality of life | Five year outcome | Yes |
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