Gallbladder Inflammation, Gall Bladder Pain, Gallstone, Gall Stone, Gall Stones (& [Calculus - Gall Bladder])
Conditions
Keywords
Laparoscopic cholecystectomy, Benchmarking, Surgical Outcomes, Reference values, Quality Improvement, Risk factors of surgical complications
Brief summary
The aim of this observational cohort study is to define peri- and postoperative reference values for elective laparoscopic cholecystectomy, using the achievable benchmarks of care methodology (ABC™). Another aim is to develop adjusted reference values for groups with a risk factor of severe postoperative complications. The over-arching aim is to inspire quality improvement initiatives.
Detailed description
The data source is the Swedish patient registry GallRiks, a prospective quality registry for gallbladder surgery and endoscopic retrograde cholangio-pancreatography (ERCP). The time frame will be 2015-2023. Register variables related to surgical quality will be analyzed, such as postoperative complications, perioperative adverse events, surgical duration and length of stay. The study will analyze data for the time of surgery and up to 30 days afterwards. Since the data is not yet available to the researchers the number of enrolled study participants can not be specified with certitude; therefore an anticipated number is given.
Interventions
PROCEDURELaparoscopic cholecystectomy
Laparoscopic cholecystectomy
Sponsors
Region Östergötland
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adults ≥ 18 years of age * laparoscopic primary cholecystectomy
Exclusion criteria
* patients with current acute cholecystitis, pancreatitis or cholangitis * cholecystectomy due to malignancy * other organ surgery performed at the same occasion * previous upper gastrointestinal surgery * single port access * robotic surgery * no data concerning surgical intervention
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Benchmark values of elective laparoscopic cholecystectomy | Day of surgery | The study will use the ABC methodology to identify reference values of surgical duration (minutes), perioperative cholangiography, conversion to open surgery and adverse events |
| Postoperative benchmark values of elective laparoscopic cholecystectomy | 0-30 days after surgery | The study will use the ABC methodology to identify reference values of the postoperative variables: hospital length of stay (days), abscess/infection, bleeding, biliary leakage, readmission, reoperation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adjusted benchmarks for severe complications | 0-30 days after surgery | Univariable and multivariable logistic regression analysis will be performed to detect any risk factor for severe complications after laparoscopic cholecystectomy. The factors to be investigated are body mass index (kg/m2), age (years), gender, smoking, cardiovascular disease, pulmonary disease, diabetes, immunosuppressive treatment, and treatment with anticoagulants. Adjusted benchmarks will be calculated for factor(s) that in multivariable logistic regression analysis are identified as individual risk factor(s). |
Outcome results
None listed