Global Evaluation of Cholecystectomy Knowledge and Outcomes, Indonesia

Cholecystectomy Clinical Trial

— GECKO-ID  

Official title:

Global Evaluation of Cholecystectomy Knowledge and Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06183346
• Other study ID #: GECKO-INDONESIA
• Status: Recruiting
• Start date: July 31, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: December 2023
• Source: Udayana University
• Contact: Christopher Ryalino
• Phone: +6282144224466
• Email: ryalino[@]unud.ac.id
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cholecystectomy

Locations

Country	Name	City	State
Indonesia	RSUP Prof. Ngoerah	Denpasar	Bali
Indonesia	RS Universitas Udayana	Jimbaran	Bali

Sponsors (1)

Lead Sponsor	Collaborator
Udayana University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	30-day readmission	All-cause readmission rate at 30-days after cholecystectomy, assessed as dichotomous variable (yes vs no)	30 days after surgery

External Links

•   Website for International GECKO study