GallstoneGECKONCT06223061
Global Evaluation of Cholecystectomy Knowledge and Outcomes
An observational study of Gallstone and Gallbladder Cancer, run by University of Edinburgh at 1 site in United Kingdom.
Trial summary
Cholecystectomy is amongst the most common surgical operations performed worldwide. Surgical candidates are treated for biliary pathologies, such as biliary colic, cholecystitis and gallstone pancreatitis. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Gallstone, Gallbladder Cancer, Bile Duct Injury
- How many people
- 53,708 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 31 Jul 2023to 19 Nov 2024
- 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 to 100 years
- All sexes
- Adult, Older adult
Study population: Consecutive patients, admitted to hospital within the pre-specified data collection periods, undergoing cholecystectomy as the index operation.
Who may be able to join
- Age: All adult patients (greater than or including 18 years of age).
- Procedure: Primary cholecystectomy, where this is the main procedure planned.
- Approach: Open, laparoscopic (standard and single-port), and robotic. Gasless laparoscopic and robotic approaches are inluded. Laparoscopic and robot converted cases are also eligible.
- Urgency: Elective, delayed and emergency procedures.
Who cannot join
- Procedure: Patients having a cholecystectomy as a part of another surgical procedure; for example, Whipple's procedure, bariatric, anti-reflux, or transplant operations, should be excluded.
- Indication: Patients with Mirizzi syndrome should be excluded.
- Return to theatre: Each patient should only be entered into the study once. Any patient returning to theatre and requiring a cholecystectomy for whatever indication, should not be included.
- Known gallbladder malignancy: when the diagnosis of gallbladder cancer is established pre-operatively, the patient should be excluded. However, if gallbladder cancer is found unexpectedly during or after cholecystectomy (i.e. on histology), the patient should be included.
Trial locations and contacts
1 site in 1 country.
About this study
Cholecystectomy is amongst the most common surgical operations performed worldwide. Surgical candidates are treated for biliary pathologies, such as biliary colic, cholecystitis and gallstone pancreatitis. In patients who are deemed fit for surgery, cholecystectomy can be performed under three main settings: (1) emergency setting at index admission; (2) elective setting with no previous admissions; or (3) delayed setting with one or more previous gallbladder-related admissions.
The advent of laparoscopy fundamentally evolved biliary surgery and quickly became the "gold standard" approach. Recent multicentre collaborative studies have elucidated that the burden imposed on healthcare systems by laparoscopic cholecystectomies is primarily due to patient readmissions and complications arising from the operation, rather than perioperative mortality burden that was more commonly seen in open surgery. As a result, national and international societies have shifted their focus towards creating a culture of safety around this procedure, with the overarching goal of improving patient satisfaction and reducing hospital costs. The universal establishment of safe cholecystectomy is a complex process that relies not only on the operation itself, but also on various other factors such as promoting adequate training, improving hospital infrastructure, and enhancing perioperative patient care.
There remains a paucity of evidence around the variations of safe provision of laparoscopic surgery for gallbladder disease internationally, including low- and middle-income countries. To bridge this knowledge gap, the Global Evaluation of Cholecystectomy Knowledge and Outcomes (GECKO) study (GlobalSurg 4) will be an international collaborative effort, delivered by the GlobalSurg network, that will allow contemporaneous data collection on the quality of cholecystectomies using measures covering infrastructure, care processes and outcomes. It will be disseminated via contacts from the National Institute for Health and Care Research (NIHR) Global Surgery unit, leading emergency general surgeons and specialist organisations.
- Conditions
- Gallstone, Gallbladder Cancer, Bile Duct Injury
- Medical subject headings
- Gallstones, Gallbladder Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance to pre-, intra-, and post-operative audit standards
Compliance to audit standards are defined as follows:
- Pre-operative: For patients with acute cholecystitis, surgeons may use the Tokyo Guidelines 18.
- Intraoperative: The use of the critical view of safety during laparoscopic cholecystectomy is the recommended approach to correctly identify relevant anatomy and minimize the risk of bile duct injuries
- Postoperative: 30-day readmission should be <10%.
Measured: 30-days from surgery
Secondary outcomes (3)
Quality of provision of cholecystectomy
The quality will be assessed according to the rates of overall complications defined as the presence of Grade I to grade V Clavien-Dindo complication.
Measured: 30-days of surgery
Adverse events following cholecystectomy (e.g., bile duct injury) and their management.
Occurence of bile duct injury within 30-days of surgery will be defined according to the Strasberg Classification
Measured: 30-days of surgery
Rates of unsuspected gallbladder cancer.
The rates of gallbladder cancer will be assessed at 1-year from the index surgery once the histology results are available.
Measured: 1-year from surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start31 Jul 2023
- Primary completion19 Nov 2023
- Study completion19 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for GallstoneStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- 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
- 53,708 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- University of Birmingham
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06223061
- Sponsor's protocol ID
- GlobalSurg 4 Edinburgh
- Acronym
- GECKO
- Status last verified
- Mar 2025
- First submitted
- 30 Nov 2023
- Last updated
- 14 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
NIHR Global Health Research Unit on Global Surgery and the GlobalSurg Collaborative. Safety and equity in scaling minimally invasive surgery worldwide in 109 countries using cholecystectomy as a tracer procedure: a prospective cohort study. Lancet Glob Health. 2026 Feb;14(2):e199-e212. doi: 10.1016/S2214-109X(25)00476-0.
PubMed 41519150Harrison E, Kathir Kamarajah S; NIHR Global Health Research Unit on Global Surgery. Global evaluation and outcomes of cholecystectomy: protocol for a multicentre, international, prospective cohort study (GlobalSurg 4). BMJ Open. 2024 Jul 25;14(7):e079599. doi: 10.1136/bmjopen-2023-079599.
PubMed 39059804
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 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
- NCT06223061
- Acronym / sponsor ID
- GECKO / GlobalSurg 4 Edinburgh
- Conditions
- Gallstone, Gallbladder Cancer, Bile Duct Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53,708 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- University of Birmingham
- Study start
- 31 Jul 2023 (actual)
- Primary completion
- 19 Nov 2023 (actual)
- Study completion
- 19 Nov 2024 (actual)
- First posted
- 25 Jan 2024 (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.
Cholecystectomy is amongst the most common surgical operations performed worldwide. Surgical candidates are treated for biliary pathologies, such as biliary colic, cholecystitis and gallstone pancreatitis. In patients who are deemed fit for surgery, cholecystectomy can be performed under three main settings: (1) emergency setting at index admission; (2) elective setting with no previous admissions; or (3) delayed setting with one or more previous gallbladder-related admissions.
The advent of laparoscopy fundamentally evolved biliary surgery and quickly became the "gold standard" approach. Recent multicentre collaborative studies have elucidated that the burden imposed on healthcare systems by laparoscopic cholecystectomies is primarily due to patient readmissions and complications arising from the operation, rather than perioperative mortality burden that was more commonly seen in open surgery. As a result, national and international societies have shifted their focus towards creating a culture of safety around this procedure, with the overarching goal of improving patient satisfaction and reducing hospital costs. The universal establishment of safe cholecystectomy is a complex process that relies not only on the operation itself, but also on various other factors such as promoting adequate training, improving hospital infrastructure, and enhancing perioperative patient care.
There remains a paucity of evidence around the variations of safe provision of laparoscopic surgery for gallbladder disease internationally, including low- and middle-income countries. To bridge this knowledge gap, the Global Evaluation of Cholecystectomy Knowledge and Outcomes (GECKO) study (GlobalSurg 4) will be an international collaborative effort, delivered by the GlobalSurg network, that will allow contemporaneous data collection on the quality of cholecystectomies using measures covering infrastructure, care processes and outcomes. It will be disseminated via contacts from the National Institute for Health and Care Research (NIHR) Global Surgery unit, leading emergency general surgeons and specialist organisations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients, admitted to hospital within the pre-specified data collection periods, undergoing cholecystectomy as the index operation.
Key inclusion criteria (4 listed)
- Age: All adult patients (greater than or including 18 years of age).
- Procedure: Primary cholecystectomy, where this is the main procedure planned.
- Approach: Open, laparoscopic (standard and single-port), and robotic. Gasless laparoscopic and robotic approaches are inluded. Laparoscopic and robot converted cases are also eligible.
- Urgency: Elective, delayed and emergency procedures.
Key exclusion criteria (4 listed)
- Procedure: Patients having a cholecystectomy as a part of another surgical procedure; for example, Whipple's procedure, bariatric, anti-reflux, or transplant operations, should be excluded.
- Indication: Patients with Mirizzi syndrome should be excluded.
- Return to theatre: Each patient should only be entered into the study once. Any patient returning to theatre and requiring a cholecystectomy for whatever indication, should not be included.
- Known gallbladder malignancy: when the diagnosis of gallbladder cancer is established pre-operatively, the patient should be excluded. However, if gallbladder cancer is found unexpectedly during or after cholecystectomy (i.e. on histology), the patient should be included.
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
Compliance to pre-, intra-, and post-operative audit standards
Time frame: 30-days from surgery
Compliance to audit standards are defined as follows: 1. Pre-operative: For patients with acute cholecystitis, surgeons may use the Tokyo Guidelines 18. 2. Intraoperative: The use of the critical view of safety during laparoscopic cholecystectomy is the recommended approach to correctly identify relevant anatomy and minimize the risk of bile duct injuries 3. Postoperative: 30-day readmission should be <10%.
3 secondary outcomes
Quality of provision of cholecystectomy
Time frame: 30-days of surgery
Adverse events following cholecystectomy (e.g., bile duct injury) and their management.
Time frame: 30-days of surgery
Rates of unsuspected gallbladder cancer.
Time frame: 1-year from 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 14 Mar 2025.
- Derived from this study: PubMed 41519150NIHR Global Health Research Unit on Global Surgery and the GlobalSurg Collaborative. Safety and equity in scaling minimally invasive surgery worldwide in 109 countries using cholecystectomy as a tracer procedure: a prospective cohort study. Lancet Glob Health. 2026 Feb;14(2):e199-e212. doi: 10.1016/S2214-109X(25)00476-0.
- Derived from this study: PubMed 39059804Harrison E, Kathir Kamarajah S; NIHR Global Health Research Unit on Global Surgery. Global evaluation and outcomes of cholecystectomy: protocol for a multicentre, international, prospective cohort study (GlobalSurg 4). BMJ Open. 2024 Jul 25;14(7):e079599. doi: 10.1136/bmjopen-2023-079599.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gallstone and Gallbladder Cancer, run by University of Edinburgh at 1 site in United Kingdom.
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 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
Compliance to pre-, intra-, and post-operative audit standards (time frame: 30-days from surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06223061, which also lists 2 linked publications.
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 14 Mar 2025.