Cholecystitis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients with a definitive diagnosis of calculous cholecystitis following the Tokyo Guideline Criteria:Symptoms of cholecystitis persisting for 7 days or longer at time of diagnosisAge =18 years
Exclusion criteria
Exclusion criteria: Inability to comprehend the study (preventing informed consent).Concomitant pancreatitis.Gallbladder fistula.Active locoregional malignancy.Pregnancy.Absolute contraindications for general anaesthesia (e.g. hemodynamic instability), as determined by the attending anaesthesiologist.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint: overall morbidity (composite outcome of: intra -or postoperative complications, failure of conservative treatment and readmissions or emergency consultations) within one-year follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: all individual components of the composite endpoint, total days admitted to the hospital, all complications graded Clavien-Dindo grade =22, recurrent biliary events, bile duct injury, patient satisfaction, quality of life, re-admissions or emergency consultations, duration of surgery, conversion-rate and costs. | — |
Countries
Netherlands
Contacts
St. Antonius Ziekenhuis