Benchmarks in Acute Laparoscopic Cholecystectomy

Region Östergötland

Status: Completed

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

Treatments: Procedure: Laparoscopic cholecystectomy

Study type: Observational

Funder types: Other

Identifiers

NCT06693076

2024-06020-02

Details and patient eligibility

About

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.

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. As the researchers do not yet have the data available, the exact number of enrolled participants can not yet be given.

Enrollment: 40,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

40,000 participants in 1 patient group

Acute laparoscopic cholecystectomy

Description:

Patients with gallbladder inflammation. ERCP may be involved if a gallstone is detected in the common bile duct perioperatively.

Treatment:

Procedure: Laparoscopic cholecystectomy