]>
IRCT20240724062536N1 IRCT 2025-02-28 Tehran University of Medical Sciences Ursodeoxycholic Acid (UDCA) and Atorvastatin Efficacy on Gallstone Prevention After Bariatric Surgery Combined and Individual Effects of Ursodeoxycholic Acid (UDCA) and Atorvastatin on Gallstone Prevention After Bariatric Surgery: a 2^2 factorial triple-blinded randomised controlled trial 2024-10-06 anticipated 308 Complete https://irct.ir/trial/78372 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Factorial, Purpose: Treatment, Randomization description: In this study, patients are assigned to treatment groups using a stratified block randomization (block size 8) method using Microsoft Excel software. Treatment groups are first identified in blocks of 8, and then a random number is generated for each patient using the RAND() function. These random values ​​are used to randomly sort the blocks. Patients are assigned sequentially from the randomized list in the order of enrollment to maintain a balance in the number of patients in each group. Treatment groups include UDCA + atorvastatin, UDCA alone, atorvastatin alone, and placebo. Technically, patient allocation is performed at the time of enrollment using the INDEX() function, which assigns a treatment group to a new patient from the randomized list. This method ensures that patients are distributed fairly and without bias to the treatment groups. The study is designed as a triple-blind design, meaning that the patient, the evaluating physician, and the data analyst are unaware of the assigned treatment group. This method in Excel allows for simple and reproducible randomization without the need for complex statistical software. In Excel, randomization is performed by combining the RAND(), SORT(), and INDEX() functions. First, RAND() generates a random number between 0 and 1 for each patient. Then, using the Sort function based on the RAND() values, the order of the patients is randomly changed. After sorting, the INDEX() function is used to assign new patients to one of the treatment groups in the order they arrive. This method is considered a practical and reliable solution for randomization in clinical studies due to its simplicity, high accuracy, and control of balance between groups, Blinding description: Patients will not know about the type of medicine provided. During each visit, the doctors will not know which type of medical intervention the patient is undergoing, and the radiologist who is responsible for the 6- and 12-month ultrasound is also unaware of the patient's group. The data analyzer will also receive a list of patient groups (1 to 4) in a protected Excel cloud file without ID and specific group type. 3 Gallstones. 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. Intervention 3: Intervention group: Atorvastatin + UDCA, in the form of two 300 mg Ursobil tablets (600 in total) and 1 40 mg Atorvastatin tablet. Intervention 4: Control group: Placebo, in the form of three tablets per day. Placebo drugs are prepared from inactive substances with no therapeutic effect and are similar in shape, color, size, and packaging to the drugs used in the treatment groups to prevent disclosure of the treatment group. Placebo is being manufactured by the Department of Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences, and its physical characteristics are designed in accordance with clinical study standards. Yes - There is a plan to make this available What will be shared: Data would be shared after de-identification of shared patients. When: Immediately after the results of the final phase of the trial were published. To whom: All researchers provided an acceptable explanation Conditions: Any use of data within the framework of the request submitted to our team will be acceptable. Where to obtain: Researchers should contact the corresponding author to access the data. The author's email and contact information are listed at the beginning of this form. shirmohamadi.erf@gmail.com How to obtain: 1. Submission of a complete request for motivation letter and the type of analysis in question on the trial database 2. Providing complete information about the location of the secondary study and the group along with the details of the people involved in the study After studying the necessary information and requesting more information, the group will notify the applicant of the decision within 3 month. Comments:
public Erfan Shirmohamadi
Keshavarz Blvd
Tehran Iran (Islamic Republic of) 5183833313 +98 41 3440 3475 shirmohamadi.erf@gmail.com Tehran University of Medical Sciences scientific Erfan Shirmohamadi
Keshavarz Blvd
Tehran Iran (Islamic Republic of) 5183833313 +98 41 3440 3475 shirmohamadi.erf@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) 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. 18 years 65 years Both 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. K80.2 Calculus of gallbladder without cholecystitis Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: UDCA only,Ursobil at a dose of 600 twice a day and a placebo tablet Intervention group: Atorvastatin, 40 mg once daily and two placebo tablets Intervention group: Atorvastatin + UDCA, in the form of two 300 mg Ursobil tablets (600 in total) and 1 40 mg Atorvastatin tablet Control group: Placebo, in the form of three tablets per day. Placebo drugs are prepared from inactive substances with no therapeutic effect and are similar in shape, color, size, and packaging to the drugs used in the treatment groups to prevent disclosure of the treatment group. Placebo is being manufactured by the Department of Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences, and its physical characteristics are designed in accordance with clinical study standards. Gallstones incidence. Timepoint: At 6 month and 1 year. Method of measurement: Sonography. Cholecystitis. Timepoint: 6 month and 1 year. Method of measurement: History and Sonography. Tehran University of Medical Sciences Approved 2024-12-30 Ethics Committee of Tehran University of Medical Sciences - Imam Khomeini Hospital, Tehran Keshavarz Boulevard, Imam Khomeini Hospital, Tehran, Ethics Committee, Research Unit Tehran Tehran Iran (Islamic Republic of)