Global Evaluation of Cholecystectomy Knowledge and Outcomes, Indonesia

Recruiting

• Conditions: Cholecystectomy

• Registration Number: NCT06183346
• Lead Sponsor: Udayana University

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

Study Timeline

• Study First Submitted: 2023-07-14
• Study Start: 2023-07-31
• Status Verified: 2023-12
• Study First Submitted QC: 2023-12-13
• Last Update Submitted: 2023-12-13
• Study First Posted: 2023-12-27
• Last Update Posted: 2023-12-27
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (2)

RS Universitas Udayana; 🇮🇩 Jimbaran, Bali, Indonesia

RSUP Prof. Ngoerah; 🇮🇩 Denpasar, Bali, Indonesia