Benchmarks in Elective Laparoscopic Cholecystectomy

Region Östergötland

Status: Completed

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

Treatments: Procedure: Laparoscopic cholecystectomy

Study type: Observational

Funder types: Other

Identifiers

NCT06692517

2022-04311-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

60,000 participants in 1 patient group

Elective cholecystectomy

Description:

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.

Treatment:

Procedure: Laparoscopic cholecystectomy