Global Evaluation of Cholecystectomy Knowledge and Outcomes (GECKO)

Cholecystectomy is amongst the most common surgical operations performed worldwide. Surgical candidates are treated for biliary pathologies, such as biliary colic, cholecystitis and gallstone pancreatitis. In patients who are deemed fit for surgery, cholecystectomy can be performed under three main settings: (1) emergency setting at index admission; (2) elective setting with no previous admissions; or (3) delayed setting with one or more previous gallbladder-related admissions.

The advent of laparoscopy fundamentally evolved biliary surgery and quickly became the "gold standard" approach. Recent multicentre collaborative studies have elucidated that the burden imposed on healthcare systems by laparoscopic cholecystectomies is primarily due to patient readmissions and complications arising from the operation, rather than perioperative mortality burden that was more commonly seen in open surgery. As a result, national and international societies have shifted their focus towards creating a culture of safety around this procedure, with the overarching goal of improving patient satisfaction and reducing hospital costs. The universal establishment of safe cholecystectomy is a complex process that relies not only on the operation itself, but also on various other factors such as promoting adequate training, improving hospital infrastructure, and enhancing perioperative patient care.

There remains a paucity of evidence around the variations of safe provision of laparoscopic surgery for gallbladder disease internationally, including low- and middle-income countries. To bridge this knowledge gap, the Global Evaluation of Cholecystectomy Knowledge and Outcomes (GECKO) study (GlobalSurg 4) will be an international collaborative effort, delivered by the GlobalSurg network, that will allow contemporaneous data collection on the quality of cholecystectomies using measures covering infrastructure, care processes and outcomes. It will be disseminated via contacts from the National Institute for Health and Care Research (NIHR) Global Surgery unit, leading emergency general surgeons and specialist organisations.

Study Overview

• Status: Recruiting
• Conditions: Gallbladder Cancer; Gallstone; Bile Duct Injury

• Study Type: Observational
• Enrollment (Estimated): 30000

Contacts and Locations

• Study Contact: Name: Ewen M Harrison; Phone Number: +44 7974 420495; Email: ewen.harrison@ed.ac.uk
• Study Contact Backup: Name: Sivesh K Kamarajah; Phone Number: +44 7471397404; Email: s.k.kamarajah@bham.ac.uk

Study Locations

• United Kingdom
  • Edinburgh, United Kingdom
    • Recruiting
    • University of Edinburgh
    • Contact: Ewen Harrison

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients, admitted to hospital within the pre-specified data collection periods, undergoing cholecystectomy as the index operation.

Description

Inclusion Criteria:

• Age: All adult patients (greater than or including 18 years of age).
• Procedure: Primary cholecystectomy, where this is the main procedure planned.
• Approach: Open, laparoscopic (standard and single-port), and robotic. Gasless laparoscopic and robotic approaches are inluded. Laparoscopic and robot converted cases are also eligible.
• Urgency: Elective, delayed and emergency procedures.

Exclusion Criteria:

• Procedure: Patients having a cholecystectomy as a part of another surgical procedure; for example, Whipple's procedure, bariatric, anti-reflux, or transplant operations, should be excluded.
• Indication: Patients with Mirizzi syndrome should be excluded.
• Return to theatre: Each patient should only be entered into the study once. Any patient returning to theatre and requiring a cholecystectomy for whatever indication, should not be included.
• Known gallbladder malignancy: when the diagnosis of gallbladder cancer is established pre-operatively, the patient should be excluded. However, if gallbladder cancer is found unexpectedly during or after cholecystectomy (i.e. on histology), the patient should be included.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compliance to pre-, intra-, and post-operative audit standards	Compliance to audit standards are defined as follows: Pre-operative: For patients with acute cholecystitis, surgeons may use the Tokyo Guidelines 18.; Intraoperative: The use of the critical view of safety during laparoscopic cholecystectomy is the recommended approach to correctly identify relevant anatomy and minimize the risk of bile duct injuries; Postoperative: 30-day readmission should be <10%.	30-days from surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of provision of cholecystectomy	The quality will be assessed according to the rates of overall complications defined as the presence of Grade I to grade V Clavien-Dindo complication.	30-days of surgery
Adverse events following cholecystectomy (e.g., bile duct injury) and their management.	Occurence of bile duct injury within 30-days of surgery will be defined according to the Strasberg Classification	30-days of surgery
Rates of unsuspected gallbladder cancer.	The rates of gallbladder cancer will be assessed at 1-year from the index surgery once the histology results are available.	1-year from surgery

Collaborators and Investigators

• Sponsor: University of Edinburgh
• Collaborators: University of Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2023
• Primary Completion (Estimated): January 31, 2024
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: November 30, 2023
• First Submitted That Met QC Criteria: January 15, 2024
• First Posted (Actual): January 25, 2024

Study Record Updates

• Last Update Posted (Actual): January 25, 2024
• Last Update Submitted That Met QC Criteria: January 15, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Pathological Conditions, Anatomical; Gallbladder Diseases; Biliary Tract Diseases; Calculi; Cholelithiasis; Cholecystolithiasis; Biliary Tract Neoplasms; Gallstones; Gallbladder Neoplasms
• Other Study ID Numbers: GlobalSurg 4 Edinburgh

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No