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IRCT20200708048049N1 IRCT 2020-08-12 Shahid Beheshti University of Medical Sciences The effect of using ursodeoxycholic acid in incident of gallstone in laparoscopic sleeve gastrectomy Comparison of using ursodeoxycholic acid and using placebo in incident of gallstone after laparoscopic gastrectomy 2020-01-21 anticipated 100 Complete https://irct.ir/trial/49543 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients are randomly divided into two groups with using ursodeoxycholic acid and using placebo .we used a random number table for randomization of Patients in two groups, Blinding description: Patients, Evaluator and analyzers are blind to the study. The form of pill was the same in both groups, and the Patients, Evaluator and analyzers did not know what group the patients are in. N/A Morbid obesity. Intervention 1: Intervention group:Treated with using ursodeoxycholic (kushan pharmed, Tehran, Iran) daily. Intervention 2: Control group:Treated with using placebo daily. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Nasser Malekpour Alamdari
Shaid Behesht University of Medical Sciences, Arabi street, Velenjak.
Tehran Iran (Islamic Republic of) 1998734383 +98 21 2207 4089 nassermalekpour@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Nasser Malekpour Alamdari
Shaid Behesht University of Medical Sciences, Arabi street, Velenjak
Tehran Iran (Islamic Republic of) 1998734383 +98 21 2207 4089 nassermalekpour@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) - patients undergoing Laparoscopic sleeve gastrectomy - morbid obesity (BMI more than 40 kg/m2 in healthy people and more than 35 kg/m2 with comorbidity) no limit no limit Both - patient with past history of cholecystectomy - patient with gallbladder agenesia -patient who didn't sign the consent form. E66.8 Other obesity Treatment - Drugs Placebo Intervention group:Treated with using ursodeoxycholic (kushan pharmed, Tehran, Iran) daily Control group:Treated with using placebo daily Gallstone. Timepoint: Before sleeve gastrectomy surgery, 6 and 12 months after surgery. Method of measurement: Ultrasound. Shahid Beheshti University of Medical Sciences Approved 2020-06-28 Ethics committee of Shahid Beheshti University of Medical Sciences School of Medicine, Shahid Beheshti University of Medical Sciences, Arabi Ave., Daneshjoo Blvd., Velenjak Tehran Tehran Iran (Islamic Republic of)