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IRCT20230815059154N1 IRCT 2023-08-26 Shiraz University of Medical Sciences Effect of calcitriol on post-percutaneous nephrolithotomy inflammation The effect of preoperative calcitriol on inflammatory markers following percutaneous nephrolithotomy (PCNL): a randomized controlled trial 2023-08-23 anticipated 14 Complete https://irct.ir/trial/72071 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients will be divided into placebo groups and the study group in a 1 to 1 ratio and block randomization. This randomization is done by the following website: https://www.sealedenvelope.com/simple-randomiser/v1/lists In this type of randomization, which helps to equalize the number of samples in two groups, patients are divided into blocks (for example, 4, 6, or 8 people) in which an equal number of patients from each group are placed in each block. Then, blocks are selected randomly by the above site and randomization is done. Using the site, a list of the order of patients belonging to each group is prepared. The drug package related to the placebo and the drug is the same, it has no name and the patient cannot distinguish whether it is a placebo or a drug, but the surgeon knows the content of the ampoule and according to the random list prepared, the drug or placebo will be injected to the patient after re-explanation, Blinding description: Participants are blinded to the study. The drug package related to placebo and drug is the same, it does not have a name, and the patient cannot distinguish whether it is a placebo or a drug, but the surgeon knows the contents of the ampule. 3 Kidney stone. Intervention 1: Intervention group: 2 mcg intravenous calcitriol injection two hours before the operation. Intervention 2: Control group: intravenous normal saline injection two hours before the operation. Yes - There is a plan to make this available What will be shared: As long as we want to share the result of our study, we will write a paper that contains all the information about our study, such as method, analysis, and results. Also, if the journal or other researchers ask us to share our patients' data and their informed consent, we will be ready to share them. When: After the paper is published To whom: All the researchers that prove they are researchers Conditions: Researchers can use the data only for their personal use. The data cannot be used for their papers because it causes data duplication. Where to obtain: By sending an email to the corresponding author who is Dr. Haghpanah. His email address: rezahaghpanah@yahoo.com How to obtain: Researcher who needs our data must introduce his/her completely (including his/her name and family name, occupation, place of work, address) and introduce us two to three of his/her previous studies along with the request email. After the researchers' information is confirmed by the responsible author, the documents will be sent to them as soon as possible after receiving the email. Before sending, the documents or files are checked for the personal information of the patients, and if any part of the information is personal, such as their name and national code, that information is deleted from the documents so that the identity of the patients is not revealed. Comments:
public Abdolreza Haghpanah
Shahid Faghihi hospital, Zand Ave.
Shiraz Iran (Islamic Republic of) 7134846114 +98 71 3235 1087 rezahaghpanah@yahoo.com Shiraz University of Medical Sciences scientific Abdolreza Haghpanah
Shahid Faghihi hospital, Zand Ave,
Shiraz Iran (Islamic Republic of) 7134846114 +98 71 3235 1087 rezahaghpanah@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Patients above 18 years of age Patients undergoing percutaneous nephrolithotomy 18 years no limit Both Using vitamin D supplements Serum vitamin D level above 100 nmol/L High serum calcium level Using of NSAID drugs Previous allergic reactions to calcitriol Having metabolic bone diseases Not willing to participate in the study N20 Calculus of kidney and ureter Treatment - Drugs Treatment - Drugs Intervention group: 2 mcg intravenous calcitriol injection two hours before the operation Control group: intravenous normal saline injection two hours before the operation Serum inflammatory factors. Timepoint: Before operation and 24 hours after operation. Method of measurement: Laboratory kits. Shiraz University of Medical Sciences Approved 2023-07-15 Ethics committee of Shiraz University of Medical Sciences Central building of Shiraz University of Medical Sciences, in front of Palestine street, Zand Ave. Shiraz Fars Iran (Islamic Republic of)