Global Evaluation of Cholecystectomy Knowledge and Outcomes, Indonesia

Study Overview
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Brief Summary
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GECKO is a prospective, international, multicentre, observational cohort study delivered by GlobalSurg Collaborative. This will be on consecutive patients undergoing cholecystectomy, between 31st July 2023 to 19th November 2023, with follow-up at 30-day and one-year postoperatively. Mini-teams of up to five collaborators per 14-day data collection period will prospectively collect data at each participating centre. The primary aim is to define the global variation in compliance to pre-, intra-, and post-operative audit standards. The subjects will be observed and interviewed during pre-surgery hospitalization up to one-year post-surgery.

Detailed Description
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Audit Standards include: Pre-operative Interventional radiology service Risk Stratification (Tokyo Guidelines). Timing of surgery Intraoperative Critical Safety View (CVS) Intraoperative imaging Bailout Procedures Antibiotic use Use of drains Bile Duct Injury (BDI) Postoperative 30-day readmission Critical Care

Official Title
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Global Evaluation of Cholecystectomy Knowledge and Outcomes

Conditions
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Cholecystectomy

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All adult patients (greater than or including 18 years of age) Undergo primary cholecystectomy (as the main procedure) Any open, laparoscopic, robotic approaches are eligible Elective, delayed and emergency cholecystectomy Exclusion Criteria: Cholecystectomy as a part of another surgical procedure (Whipple's, bariatric, transplant) Patients with Mirizzi syndrome Patients returning to theatre and requiring a cholecystectomy for whatever indication Known gallbladder malignancy: Gallbladder cancer diagnosed preoperatively

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Main Cohort (Single Cohort)<br>The main cohort consists of all patients who will undergo either emergency/urgent/delayed/elective cholecystectomy in all participating hospitals in Indonesia. Inclusion/exclusion criteria will be applied. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day mortality | All-cause mortality rate at 30-days after cholecystectomy, assessed as dichotomous variable (survivor vs non-survivor) | 30 days after the surgery | 
| 1-year mortality | All-cause mortality rate at 1-year after cholecystectomy, assessed as dichotomous variable (survivor vs non-survivor) | 1 year after the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Critical care admission | All-cause ICU admission rate at 24-hours after cholecystectomy, assessed as dichotomous variable (yes vs no) | 24 hours after the surgery | 
| 30-day readmission | All-cause readmission rate at 30-days after cholecystectomy, assessed as dichotomous variable (yes vs no) | 30 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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surgery, cholecystectomy, robotic, audit, international, multicentre, prospective, observational