Benchmarks in Acute Laparoscopic Cholecystectomy
- Conditions
- GallbladderGall Stones (&Amp; [Calculus - Gall Bladder])Gall StoneGallbladder Inflammation
- Registration Number
- NCT06693076
- Lead Sponsor
- Region Östergötland
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40000
- adults ≥ 18 years of age
- laparoscopic acute cholecystectomy
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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).