Benchmarks in Elective Laparoscopic Cholecystectomy

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.

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Key information

Conditions

Gall Stone Biliary Tract Diseases Calculi Cholecystitis Cholecystolithiasis Cholelithiasis Digestive System Diseases Gall Bladder Pain Gall Stones (& [Calculus - Gall Bladder]) Gallbladder Diseases Gallbladder Inflammation Gallstone Gallstones Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laparoscopic cholecystectomy

Procedure

Laparoscopic cholecystectomy

Primary outcomes

Benchmark values of elective laparoscopic cholecystectomy

Time frame: 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

Time frame: 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 outcomes

Adjusted benchmarks for severe complications

Time frame: 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).

Sponsors and collaborators

Lead sponsor

Region Östergötland

Other

Registry information

Official study title

Benchmarks in Elective Laparoscopic Cholecystectomy - a National Registry Study

Important dates

Study start: 2015
Primary completion: 2023
Study completion: 2023
First posted: Nov 18, 2024
Registry last updated: Dec 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed