Gallbladder, Gallbladder Inflammation, Gall Stone, Gall Stones (&Amp; [Calculus - Gall Bladder])
Conditions
Keywords
laparoscopic cholecystectomy, benchmarking, surgical outcomes, reference values, quality improvement
Brief summary
The aim of this observational cohort study is to define peri- and postoperative reference values for acute 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 goal is to spur 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. As the researchers do not yet have the data available, the exact number of enrolled participants can not yet be given.
Interventions
PROCEDURELaparoscopic cholecystectomy
The intervention in this study is urgent, not elective. The conditions for the surgery are therefore different: any time of day, the surgeon on shift, the state of the patients.
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 acute cholecystectomy
Exclusion criteria
* other indications than acute cholecystitis will be excluded * 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 acute 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 acute laparoscopic cholecystectomy | 0-30 days after surgery | The study will use the ABC methodology to identify reference values of 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 acute 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