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:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2025-12-26 @ 1:16 PM
NCT ID:
NCT06405906
Eligibility Criteria:
Inclusion Criteria (RADIGAL1):
* 18 years old or older
* presenting with biliary colic in the ED or outpatient clinic, with the surgical team deciding to proceed with non-operative treatment (Group 1)
* presenting with acute calculous cholecystitis in the ED, with the surgical team deciding to proceed with non-operative management (Group 2)
Exclusion Criteria (RADIGAL1):
* history of gastrointestinal disease which might affect diet, e.g., inflammatory bowel disease, irritable bowel syndrome, short bowel syndrome
* inability to provide informed consent
* unwillingness to adhere to the recommended diet
* food allergies or intolerances that would prevent following the diet
* dietary habits (e.g., vegetarians, vegans) that preclude adherence to the recommended diet
* gallstone related cholangitis without biliary colic or cholecystitis
* complications from acute pancreatitis, such as pseudocysts, walled off necrosis, among others
Inclusion Criteria (RADIGAL2):
* 18 years old or older
* undergoing uncomplicated cholecystectomy (open or laparoscopic without bile duct exploration) due to a history of biliary colic (Group 1)
* undergoing uncomplicated cholecystectomy (open or laparoscopic without bile duct exploration) due to acute cholecystitis (Group 2)
Exclusion Criteria (RADIGAL2):
* history of gastrointestinal disease which might affect diet, e.g., inflammatory bowel disease, irritable bowel syndrome, short bowel syndrome
* inability to provide informed consent
* unwillingness to adhere to the recommended diet
* food allergies or intolerances that would prevent following the diet - dietary habits (e.g., vegetarians, vegans) that preclude adherence to the recommended diet
* gallstone related cholangitis without biliary colic or cholecystitis
* complications from acute pancreatitis, such as pseudocysts, walled off necrosis, among others
* choledocholithiasis
* complicated cholecystectomy
* patients undergoing subtotal cholecystectomy
* whether primary operation differs from cholecystectomy (e.g., colectomy)
* patients having treated with percutaneous cholecystostomy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06405906
Study Brief:
Protocol Section:
NCT06405906