Global Evaluation of Cholecystectomy Knowledge and Outcomes, Indonesia

NCT06183346 | Completed

• 1 other identifier: GECKO-INDONESIA
• Study Type: observational
• Target: 92
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Cholecystectomy

Keywords

surgery; cholecystectomy; robotic; audit; international; multicentre; prospective; observational

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Critical care admission

  24 hours after the surgery

• 30-day readmission

  30 days after surgery

Study Arms (1)

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.

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

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Udayana University: lead

Study Sites (2)

RSUP Prof. Ngoerah

Denpasar, Bali, 80114, Indonesia

Location

RS Universitas Udayana

Jimbaran, Bali, 80361, Indonesia

Location

Related Links

• Website for International GECKO study

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 14, 2023
• First Posted: December 27, 2023
• Study Start: July 31, 2023
• Primary Completion: December 31, 2024
• Study Completion: March 25, 2025
• Last Updated: June 3, 2025

Record last verified: 2025-05

Locations

ID (2)