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IRCT20191104045328N11 IRCT 2022-06-27 Arak University of Medical Sciences Comparison of the efficacy of two different doses of ethanol in sclerotherapy of simple breast cysts Comparison of the effect of two different doses of ethanol in sclerotherapy for simple skin cysts through skin under ultrasound guidance 2022-06-28 anticipated 70 Complete https://irct.ir/trial/64273 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants are assigned to two intervention and control groups, respectively, based on the randomization sequence that will be generated beforehand. This sequence is unpredictable and its arrangement is completely random. Block randomization method with 8 blocks will be used to allocate samples. Thus, using block numerical random number generation software, a randomization sequence proportional to the sample size required for the two groups will be generated. Initially, all cases in which the two letters A and B can be arranged in blocks of 8 are produced. A block is then randomly selected from the blocks and the layout pattern in that block will be used to assign participants. This block will then be placed in the main container and another block will be selected again. All this will be done with software called Sealed Envelope. With this method, concealment will also be observed. The concept of concealment is to unpredictably assign individuals to groups. In fact, the researcher will not be able to predict which group the next person will be in, Blinding description: In order to blind the resident, the dose of ethanol in the cyst is not known and the ethanols are delivered to the resident in syringes covered with foil and patients are followed up by the resident. Patients are also unaware of the grouping they are in. 3 Simple breast cyst. Intervention 1: Intervention group: After aspirating the cyst volume in a group, 99% alcohol is injected into the cyst as much as 50% of the cyst volume. Intervention 2: Intervention group: After aspirating the cyst volume in a group, 99% alcohol is injected into the cyst as much as 90% of the cyst volume. Yes - There is a plan to make this available What will be shared: After conducting this study and analytical studies on it, only a part of the data such as information about the main outcome and patient demographic information will be published to the researchers who do the necessary correspondence with the person in charge of this study. When: Access will be from 2023/4/20 to 2026/4/20 for 3 years. To whom: University researchers Conditions: Academic researchers or university professors or students who intend to use the data of this study, after obtaining permission from the relevant people mentioned, can use the information of this study in the field of metallurgical studies or other relevant review studies. In addition, if requested, they can use the information of this study for the prerequisites of their future studies and the existence of questions and ambiguities. Using the information of this study is subject to mentioning the names and logos of the responsible persons in this study. Where to obtain: University researchers and university professors, after contacting the relevant professor by text message or e-mail, can request the use of data from Dr. Safi and then Dr. Bashiri, respectively. Dr. Fatemeh Safi: Address: Valiasr Hospital, Shahid Shiroodi St., Arak Postal Code: 3814957558 Phone: 09183617577 Email: safiarak95@gmail.com Dr. Soodabeh Bashiri Address: Valiasr Hospital, Shahid Shiroodi St., Arak Postal Code: 3814957558 Phone: 09181413783 Email: dr.bashiri1985@gmail.com How to obtain: Letter writing should be done with professors and universities. Comments:
public Dr Sedigheh Darvish Shafiqi
Vali Asr hospital, Shahid Shiroudi Street, Arak, Iran
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 Sedighehdarvish@arakmua.ac.ir Arak University of Medical Sciences scientific Dr Fatemeh Safi
Vali Asr hospital, Shahid Shiroudi Street, Arak, Iran
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 safiarak95@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) Women with simple breast cysts that are 10 mm and larger in size. Age 20-60 years Lack of treatment of cysts Satisfaction to participate in the study 20 years 60 years Female Having a history of breast cancer in yourself and first-degree relatives Pregnancy Breastfeeding N60.0 Solitary cyst of breast Treatment - Drugs Treatment - Drugs Intervention group: After aspirating the cyst volume in a group, 99% alcohol is injected into the cyst as much as 50% of the cyst volume. Intervention group: After aspirating the cyst volume in a group, 99% alcohol is injected into the cyst as much as 90% of the cyst volume. Breast cyst volume. Timepoint: Before sclerotherapy, three months after sclerotherapy, 6 months after sclerotherapy. Method of measurement: sonography. The largest length of a breast cyst. Timepoint: Before sclerotherapy, three months after sclerotherapy, 6 months after sclerotherapy. Method of measurement: sonography. The largest width of the breast cyst. Timepoint: Before sclerotherapy, three months after sclerotherapy, 6 months after sclerotherapy. Method of measurement: sonography. The largest height of the breast cyst. Timepoint: Before sclerotherapy, three months after sclerotherapy, 6 months after sclerotherapy. Method of measurement: sonography. Arak University of Medical Sciences Approved 2021-11-17 Ethics Committee of Arak University of Medical Sciences Research Assistant, Arak University of Medical Sciences, Basij Square, Sardasht, Arak, Iran Arak Markazi Iran (Islamic Republic of)