Status:

RECRUITING

A Randomized Controlled Trial Comparing Fat-free Versus Balanced (WHO) Diet in Gallstone Disease

Lead Sponsor:

University Hospital of Crete

Conditions:

Gallstone Disease

Gallstone; Colic

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

The goal of this trial is to assess the effect on the quality of life (QoL) of recommending a fat-free diet versus a balanced WHO diet in symptomatic patients with gallstones and in patients undergoin...

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

Key Trial Info

Start Date :

March 27 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2025

Estimated Enrollment :

242 Patients enrolled

Trial Details

Trial ID

NCT06405906

Start Date

March 27 2024

End Date

December 1 2025

Last Update

May 9 2024

Active Locations (1)

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1

Department of Surgery, University Hospital of Heraklion

Heraklion, Greece, 71110