Gallstones. Calculus of gallbladder without cholecystitis
Conditions
Interventions
Intervention 1: Intervention group: UDCA only,Ursobil at a dose of 600 twice a day and a placebo tablet. Intervention 2: Intervention group: Atorvastatin, 40 mg once daily and two placebo tablets. Int
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Adults aged 18 to 65 years who are candidates for RYGB or sleeve gastrectomy (those with a BMI higher than 35 kg/m2 or those with a BMI higher than 30 kg/m2 and with obesity-related diseases) People with a healthy gallbladder No contraindications for UDCA or atorvastatin. Willingness and ability to provide written informed consent. Individuals without severe comorbidities that could complicate surgery or recovery.
Exclusion criteria
Exclusion criteria: Those for whom gallstones have been identified in the preoperative ultrasound History of bariatric or gallbladder surgery. Use of drugs that interfere with UDCA or atorvastatin (cholestyramine, colestipol, aluminum-containing antacids, and estrogens) and intestinal conditions that interfere with the absorption of these drugs. Current use of contraindications to lipid-lowering medications (including HIV protease inhibitors such as ritonavir, warfarin, cyclosporine, verapamil, and amiodarone) People with intolerance or allergy to UDCA or atorvastatin Pregnancy or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gallstones incidence. Timepoint: At 6 month and 1 year. Method of measurement: Sonography. | — |
Secondary
| Measure | Time frame |
|---|---|
| Cholecystitis. Timepoint: 6 month and 1 year. Method of measurement: History and Sonography. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactErfan Shirmohamadi
Tehran University of Medical Sciences
Outcome results
None listed