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NCT Number: NCT06183346

Global Evaluation of Cholecystectomy Knowledge and Outcomes, Indonesia

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.

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Key information

Conditions

Cholecystectomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

RSUP Prof. Ngoerah, Denpasar, Bali, Indonesia

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About this study

Audit Standards include:

  • Pre-operative
  • Interventional radiology service
  • Risk Stratification (Tokyo Guidelines).
  • Timing of surgery
  • Intraoperative
  • Critical Safety View (CVS)
  • Intraoperative imaging
  • Bailout Procedures
  • Antibiotic use
  • Use of drains
  • Bile Duct Injury (BDI)
  • Postoperative
  • 30-day readmission
  • Critical Care

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 30-day mortality

    Time frame: 30 days after the surgery

    All-cause mortality rate at 30-days after cholecystectomy, assessed as dichotomous variable (survivor vs non-survivor)

  2. 1-year mortality

    Time frame: 1 year after the surgery

    All-cause mortality rate at 1-year after cholecystectomy, assessed as dichotomous variable (survivor vs non-survivor)

Secondary outcomes

  1. Critical care admission

    Time frame: 24 hours after the surgery

    All-cause ICU admission rate at 24-hours after cholecystectomy, assessed as dichotomous variable (yes vs no)

  2. 30-day readmission

    Time frame: 30 days after surgery

    All-cause readmission rate at 30-days after cholecystectomy, assessed as dichotomous variable (yes vs no)

Sponsors and collaborators

Lead sponsor

Udayana University

Other

Registry information

Official study title

Global Evaluation of Cholecystectomy Knowledge and Outcomes

Acronym: GECKO-ID

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Dec 27, 2023
Registry last updated
Jun 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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