Benchmarks in Elective Laparoscopic Cholecystectomy

Benchmarks in Elective Laparoscopic Cholecystectomy - a National Registry Study

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.

Study Overview

• Status: Completed
• Conditions: Gallstone; Gall Stone; Gall Stones (& [Calculus - Gall Bladder]); Gall Bladder Pain; Gallbladder Inflammation
• Intervention / Treatment: Procedure: Laparoscopic cholecystectomy

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 Type: Observational
• Enrollment (Estimated): 60000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults with gall stone disease and, or previous gallbladder inflammation.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Elective cholecystectomy; Elective cholecystectomy. Patients with recurrent gallstone attacks, previous cholecystitis, previous cholangitis, or previous pancreatitis. ERCP may be involved if a gallstone is detected in the common bile duct perioperatively.	Procedure: Laparoscopic cholecystectomy; Laparoscopic cholecystectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Benchmark values of elective laparoscopic cholecystectomy	The study will use the ABC methodology to identify reference values of surgical duration (minutes), perioperative cholangiography, conversion to open surgery and adverse events	Day of surgery
Postoperative benchmark values of elective laparoscopic cholecystectomy	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	0-30 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adjusted benchmarks for severe complications	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).	0-30 days after surgery

Collaborators and Investigators

• Sponsor: Region Östergötland

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: May 3, 2024
• First Submitted That Met QC Criteria: November 14, 2024
• First Posted (Actual): November 18, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 26, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Laparoscopic cholecystectomy; Quality Improvement; Reference values; Surgical Outcomes; Benchmarking; Risk factors of surgical complications
• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Anatomical; Digestive System Diseases; Biliary Tract Diseases; Gallbladder Diseases; Inflammation; Calculi; Cholecystitis; Gallstones; Cholelithiasis; Cholecystolithiasis
• Other Study ID Numbers: 2022-04311-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Data will be shared upon reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No