Evaluating cholecystectomy practices and outcomes in Indonesia
Global Evaluation of Cholecystectomy Knowledge and Outcomes
Udayana University · NCT06183346
This study is trying to see how well cholecystectomy surgeries are done in Indonesia and if following certain guidelines can improve patient outcomes after the surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Udayana University (other) |
| Locations | 2 sites (Denpasar, Bali and 1 other locations) |
| Trial ID | NCT06183346 on ClinicalTrials.gov |
What this trial studies
This observational cohort study, known as GECKO, aims to assess the global variation in compliance with audit standards for cholecystectomy procedures. Conducted by the GlobalSurg Collaborative, it will involve consecutive adult patients undergoing cholecystectomy from July 31, 2023, to November 19, 2023, with follow-up assessments at 30 days and one year post-surgery. Data will be collected by mini-teams at participating centers, focusing on pre-operative, intraoperative, and postoperative practices. The study will analyze factors such as risk stratification, surgical timing, and postoperative outcomes to improve surgical standards.
Who should consider this trial
Good fit: Ideal candidates include adult patients aged 18 and older who are scheduled for primary cholecystectomy, regardless of the surgical approach.
Not a fit: Patients undergoing cholecystectomy as part of another surgical procedure or those with known gallbladder malignancy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the quality and safety of cholecystectomy procedures worldwide.
How similar studies have performed: Other studies have shown success in improving surgical outcomes through similar audit and compliance assessments, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Denpasar, Bali and 1 other locations
- RSUP Prof. Ngoerah — Denpasar, Bali, Indonesia (RECRUITING)
- RS Universitas Udayana — Jimbaran, Bali, Indonesia (RECRUITING)
Study contacts
- Study coordinator: Christopher Ryalino
- Email: ryalino@unud.ac.id
- Phone: +6282144224466
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cholecystectomy, surgery, cholecystectomy, robotic, audit, international, multicentre, prospective