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

Udayana University

Status: Completed

Conditions: Cholecystectomy

Study type: Observational

Funder types: Other

Identifiers

NCT06183346

GECKO-INDONESIA

Details and patient eligibility

About

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.

Full 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

Enrollment: 92 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

92 participants in 1 patient group

Main Cohort (Single Cohort)

Description:

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.