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Benchmarks in Acute Laparoscopic Cholecystectomy

Completed
Conditions
Gallbladder
Gall Stones (&Amp; [Calculus - Gall Bladder])
Gall Stone
Gallbladder 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
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Benchmark values of acute laparoscopic cholecystectomyDay 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 cholecystectomy0-30 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
NameTimeMethod
Adjusted benchmarks for severe complications0-30 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).

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