CholecystectomyGECKO-IDNCT06183346
Global Evaluation of Cholecystectomy Knowledge and Outcomes, Indonesia
An observational study of Cholecystectomy, run by Udayana University at 2 sites in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholecystectomy
- How many people
- 92 participants
- Where
- 2 sitesIndonesia
- Study dates
- 31 Jul 2023to 25 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients undergoing cholecystectomy, between 31st July - 19th November 2023, with follow-up at 30-day and one-year postoperatively
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Indonesia2 sites
RSUP Prof. Ngoerah
Denpasar, Bali, 80114
RS Universitas Udayana
Jimbaran, Bali, 80361
About this study
Official title: Global Evaluation of Cholecystectomy Knowledge and Outcomes
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.
Read the 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
- Conditions
- Cholecystectomy
- Keywords
- surgery, cholecystectomy, robotic, audit, international, multicentre, prospective, observational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Main Cohort (Single Cohort) | The main cohort consists of all patients who will undergo either emergency/urgent/delayed/elective cholecystectomy in all participating hospitals in Indonesia. Inclusion/exclusion criteria will be applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day mortality
All-cause mortality rate at 30-days after cholecystectomy, assessed as dichotomous variable (survivor vs non-survivor)
Measured: 30 days after the surgery
1-year mortality
All-cause mortality rate at 1-year after cholecystectomy, assessed as dichotomous variable (survivor vs non-survivor)
Measured: 1 year after the surgery
Secondary outcomes (2)
Critical care admission
All-cause ICU admission rate at 24-hours after cholecystectomy, assessed as dichotomous variable (yes vs no)
Measured: 24 hours after the surgery
30-day readmission
All-cause readmission rate at 30-days after cholecystectomy, assessed as dichotomous variable (yes vs no)
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2023
- Study start31 Jul 2023
- Primary completion31 Dec 2024
- Study completion25 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholecystectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Udayana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Ryalino, MD, Udayana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06183346
- Sponsor's protocol ID
- GECKO-INDONESIA
- Acronym
- GECKO-ID
- Status last verified
- May 2025
- First submitted
- 14 Jul 2023
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Global Evaluation of Cholecystectomy Knowledge and Outcomes
- ClinicalTrials.gov ID
- NCT06183346
- Acronym / sponsor ID
- GECKO-ID / GECKO-INDONESIA
- Conditions
- Cholecystectomy
- Keywords
- surgery, cholecystectomy, robotic, audit, international, multicentre, prospective, observational
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Udayana UniversityUniversity, hospital or other
- Study start
- 31 Jul 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 25 Mar 2025 (actual)
- First posted
- 27 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Main Cohort (Single Cohort) | – | –The main cohort consists of all patients who will undergo either emergency/urgent/delayed/elective cholecystectomy in all participating hospitals in Indonesia. Inclusion/exclusion criteria will be applied. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients undergoing cholecystectomy, between 31st July - 19th November 2023, with follow-up at 30-day and one-year postoperatively
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
2 secondary outcomes
Critical care admission
Time frame: 24 hours after the surgery
30-day readmission
Time frame: 30 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
- Website for International GECKO studyLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cholecystectomy, run by Udayana University at 2 sites in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day mortality (time frame: 30 days after the surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2025.