Global Evaluation of Cholecystectomy Knowledge and Outcomes, Indonesia (GECKO-ID)

Global Evaluation of Cholecystectomy Knowledge and Outcomes

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.

Study Overview

• Status: Recruiting
• Conditions: Cholecystectomy

Detailed Description

Audit Standards include:

1. Pre-operative

   • Interventional radiology service
   • Risk Stratification (Tokyo Guidelines).
   • Timing of surgery

2. Intraoperative

   • Critical Safety View (CVS)
   • Intraoperative imaging
   • Bailout Procedures
   • Antibiotic use
   • Use of drains
   • Bile Duct Injury (BDI)

3. Postoperative

   • 30-day readmission
   • Critical Care

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Christopher Ryalino; Phone Number: +6282144224466; Email: ryalino@unud.ac.id

Study Locations

• Indonesia
  • Bali
    • Denpasar, Bali, Indonesia, 80114
      • Recruiting
      • RSUP Prof. Ngoerah
      • Contact: Tjokorda GA Senapathi, Prof; Phone Number: +6281999511100; Email: tjoksenapathi@unud.ac.id
    • Jimbaran, Bali, Indonesia, 80361
      • Recruiting
      • RS Universitas Udayana
      • Contact: Christopher Ryalino; Phone Number: +6282144224466; Email: ryalino@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients undergoing cholecystectomy, between 31st July - 19th November 2023, with follow-up at 30-day and one-year postoperatively

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Main Cohort (Single Cohort); 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?

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

Collaborators and Investigators

• Sponsor: Udayana University

Publications and helpful links

Helpful Links

• Website for International GECKO study

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: July 14, 2023
• First Submitted That Met QC Criteria: December 13, 2023
• First Posted (Estimated): December 27, 2023

Study Record Updates

• Last Update Posted (Estimated): December 27, 2023
• Last Update Submitted That Met QC Criteria: December 13, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: surgery; cholecystectomy; prospective; robotic; observational; multicentre; international; audit
• Other Study ID Numbers: GECKO-INDONESIA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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