Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:36 PM
Ignite Modification Date:
2025-12-24 @ 12:36 PM
NCT ID:
NCT06223061
Eligibility Criteria:
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT06223061
Study Brief:
Protocol Section:
NCT06223061