biliary colic cholecystolithiasis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: age 18-75 years positive history of biliary colic confirmative ultrasound examination of uncomplicated cholecystolithiasis Regular bloodtest without signs of infection or cholestasis Willingness to cooperate with random group assignment, attend office visits and comply with all tests in this protocol Oral and written Informed Consent
Exclusion criteria
Exclusion criteria: younger then 18 years patient who is legally or mentally incapable or unable to give informed consent history of previous abdominal surgery in the upper abdomen or by midline incision recent ERCP within 6 weeks of trial concomitant biliary disease at ultrasound investigation: o Choledocholithiasis o Cholecystitis o Dilatation of intra- or extrahepatic biliary structures abnormal bloodtest with elevated liverfunction and bilirubin and signs of infection (elevated CRP, leucocytes or sedimentation) contraindications to general anaesthesia or abdominal surgery including ASA >3 pregnancy at time of inclusion or at time of surgery immunosuppresion coagulation disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Combined endpoint including safety scored by photo or video of the critical view of safety and all major complications (injury of common bile duct). | — |
Secondary
| Measure | Time frame |
|---|---|
| per and postoperatieve complications: - painscore, scored by the VAS score - use of painkillers. - woundinfcetion - bilioma - bile duct lesion - trocarhernia - tissue damage, as measured by interleukines - scoring of scar | — |
Countries
Netherlands