Global Evaluation of Cholecystectomy Knowledge and Outcomes, Indonesia

Global Evaluation of Cholecystectomy Knowledge and Outcomes

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06183346

Acronym

GECKO-ID

Enrollment

Registered

2023-12-27

Start date

2023-07-31

Completion date

2025-03-25

Last updated

2025-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholecystectomy

Keywords

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

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.

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Countries

Indonesia

Outcome results