Benchmarks in Acute Laparoscopic Cholecystectomy

NCT06693076 | Completed

• 1 other identifier: 2024-06020-02
• Study Type: observational
• Target: 40,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this observational cohort study is to define peri- and postoperative reference values for 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.

Conditions

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

Keywords

laparoscopic cholecystectomy; benchmarking; surgical outcomes; reference values; quality improvement

Outcome Measures

Primary Outcomes (2)

• Benchmark values of acute 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 acute laparoscopic cholecystectomy

  The study will use the ABC methodology to identify reference values of 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)

Acute laparoscopic cholecystectomy

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

Procedure: Laparoscopic cholecystectomy

Interventions

Laparoscopic cholecystectomy PROCEDURE

The intervention in this study is urgent, not elective. The conditions for the surgery are therefore different: any time of day, the surgeon on shift, the state of the patients.

Acute laparoscopic 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 gallbladder inflammation.

You may qualify if:

• adults ≥ 18 years of age
• laparoscopic acute cholecystectomy

You may not qualify if:

• 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

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: MD

Study Record Dates

• First Submitted: November 14, 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