Global Evaluation of Cholecystectomy Knowledge and Outcomes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 92
- Locations
- 2
- Primary Endpoint
- 30-day mortality
Study Overview
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:
- 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
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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)
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
- Critical care admission(24 hours after the surgery)
- 30-day readmission(30 days after surgery)
Investigators
Christopher Ryalino, MD
Principal Investigator
Udayana University