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IRCT20210309050650N1 IRCT 2021-03-29 Zanjan University of Medical Sciences The efficacy of ursodeoxycholic acid therapy in delay cholecystectomy Evaluating the efficacy of ursodeoxycholic acid therapy in patients with acute cholecystitis who are candidates for delayed cholecystectomy in Ayatollah Mousavi Hospital in Zanjan 2021-03-21 anticipated 60 Complete https://irct.ir/trial/54923 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: A randomized block is used to randomize the patients under study and to fully observe the randomness of placement in the control group and the sample group because the inclusion process requires randomization due to the ongoing recruitment. Based on the calculated sample size, the sample size in each group is 24 people for easier application of random blocks to randomize the members of each group. Permutations are considered as 6 permutations according to 2 groups: AABB, ABAB, BBAA, BABA, BAAB, ABBA. The permutations are written on 6 cards and the selection of permutations and their order will be randomly selected from among the cards. The order of exit of the cards is written and will determine the order of recruitment of intervention groups based on it. An individual randomization unit will be used for the study. The information of the registered persons will be anonymous and without their personal information. 3 Acute Cholecystitis. Intervention 1: Intervention group: Ursodeoxycholic acid tablets with a dose of 9-10 mg/kg produced by Exir Pharmacy, will be taken orally at bedtime once a day. The duration of treatment is six weeks. Intervention 2: Control group: A placebo with the same appearance as the drug of the intervention group will be provided by a similar pharmaceutical company (Exir Pharmacy) and does not contain any active substance. It will be taken once a day, orally and at bedtime. The duration of treatment will be 6 weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Its release schedule is not yet known.
public Naser Keikhali
Ayatollah Mousavi Hospital
Zanjan Iran (Islamic Republic of) 4513956183 +98 24 3313 0000 nkeikhali@zums.ac.ir Zanjan University of Medical Sciences scientific Naser Keikhali
Department of Surgery, Ayatollah Mousavi Hospital, Gavazang Blvd
Zanjan Iran (Islamic Republic of) 4513956183 +98 24 3313 1851 nkeikhali@zums.ac.ir Zanjan University of Medical Sciences Iran (Islamic Republic of) Patient diagnosed with acute cholecystitis and candidate for delayed surgery (patients who did not present within the first 72 hours of onset) Patients who are not candidates for early surgery due to other medical problems such as severe congestive heart failure. Patient's personal consent to attend the study Stone size less than 15 mm Patients with mild symptoms or asymptomatic 18 years no limit Both Patients who are unable to tolerate ursodeoxycholic acid Patients with complicated gallstones Patients with cholangitis Patients with impaired liver tests Patients with moderate to severe symptoms Patients who become candidates for emergency surgery before the sixth week during the waiting period. K81.0 Acute cholecystitis Treatment - Drugs Placebo Intervention group: Ursodeoxycholic acid tablets with a dose of 9-10 mg/kg produced by Exir Pharmacy, will be taken orally at bedtime once a day. The duration of treatment is six weeks. Control group: A placebo with the same appearance as the drug of the intervention group will be provided by a similar pharmaceutical company (Exir Pharmacy) and does not contain any active substance. It will be taken once a day, orally and at bedtime. The duration of treatment will be 6 weeks. Patients' pain while waiting for cholecystectomy surgery. Timepoint: Patients' pain will be assessed at baseline and at 3 and 6 weeks after starting treatment. Method of measurement: Based on Visual Analogue Scale scale, data would be collected. Zanjan University of Medical Sciences Approved 2020-11-27 Ethics committee of Zanjan University of Medical Science Ayatollah Mousavi Hospital, Zanjan Zanjan Zanjan Iran (Islamic Republic of)