Clinical trial NCT06223061: Global Evaluation of Cholecystectomy Knowledge and Outcomes
Official title: Global Evaluation of Cholecystectomy Knowledge and Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gallstone
Gallbladder Cancer
Bile Duct Injury
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: University of Birmingham
First posted: 2024-01-25
Enrollment: 53708
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Compliance to pre-, intra-, and post-operative audit standards
timeFrame: 30-days from surgery
Secondary outcomes:
measure: Quality of provision of cholecystectomy
timeFrame: 30-days of surgery
measure: Adverse events following cholecystectomy (e.g., bile duct injury) and their management.
timeFrame: 30-days of surgery
measure: Rates of unsuspected gallbladder cancer.
timeFrame: 1-year from surgery
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: University of Edinburgh
Study officials:
References: