Benchmarks in Elective Laparoscopic Cholecystectomy

Completed

• Conditions: Gall Stone; Gallbladder Inflammation; Gall Bladder Pain; Gallstone; Gall Stones (& [Calculus - Gall Bladder])

• Registration Number: NCT06692517
• Lead Sponsor: Region Östergötland

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.

Study Timeline

• Study Start: 2015-01-01
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Study First Submitted: 2024-05-03
• Study First Submitted QC: 2024-11-14
• Study First Posted: 2024-11-18
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-26
• Last Update Posted: 2024-12-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 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 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).