Benchmarks in Elective Laparoscopic Cholecystectomy

NCT06692517 | Completed

• 1 other identifier: 2022-04311-01
• Study Type: observational
• Target: 60,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

Laparoscopic cholecystectomy; Benchmarking; Surgical Outcomes; Reference values; Quality Improvement; Risk factors of surgical complications

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Adjusted benchmarks for severe complications

  0-30 days after surgery

Study Arms (1)

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

Interventions

Laparoscopic cholecystectomy PROCEDURE

Laparoscopic cholecystectomy

Elective cholecystectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• adults ≥ 18 years of age
• laparoscopic primary cholecystectomy

You may not qualify if:

• 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

Sponsors & Collaborators

• Region Östergötland: lead

MeSH Terms

Conditions

Gallstones; Cholecystitis

Interventions

Cholecystectomy, Laparoscopic

Condition Hierarchy (Ancestors)

Cholelithiasis; Biliary Tract Diseases; Digestive System Diseases; Cholecystolithiasis; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cholecystectomy; Biliary Tract Surgical Procedures; Digestive System Surgical Procedures; Surgical Procedures, Operative; Laparoscopy; Endoscopy; Minimally Invasive Surgical Procedures

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: November 18, 2024
• Study Start: January 1, 2015
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: December 31, 2024

Record last verified: 2024-12