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IRCT20230519058228N1 IRCT 2023-05-23 Esfahan University of Medical Sciences The effect of preserving the myoma pseudocapsule wall in repairing the surgical site in patients undergoing hysteroscopic myomectomy Investigating myometrial thickness and scar vascularity compared to healthy myometrium using Doppler ultrasound in patients undergoing hysteroscopic myomectomy with and without preservation of pseudocapsule. 2023-06-10 anticipated 50 Complete https://irct.ir/trial/70247 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Randomization description: Using random allocation software, 50 selected patients are divided into two groups: removal and preservation of myoma pseudocapsule during hysteroscopic myomectomy. In the said software, the total number of sample volume (50 people) and the number of groups (2 groups) are entered into the software. The output of the software includes a list that randomly distributes the numbers 1 to 50 in two groups. Patients are distributed in two groups according to the time of referral in the order of the mentioned list so that the sample volume reaches the required number in each group, Blinding description: This study is conducted in a two-way blind method. In such a way that the patients are unaware of the type of operation (preserve or removal of myoma pseudocapsule); Also, the outcome assessor (sonographer) does not know whether to preserve or remove the myoma pseudocapsule. N/A submucousal myoma. Intervention group: women with submucousal myoma Fig. 1 During the shaving of the myoma with a resectoscope, the resectoscopy is stopped as soon as the pseudocapsule is reached and the pseudocapsule is kept in place .Three months after the operation using Doppler ultrasound, scar thickness, scar vascularity And the existence of a heterogeneous mass in the operation site is checked.. No - There is not a plan to make this available Justification or reason for not sharing IPD is The data will not be shared separately, but the results of their analysis will be shared in the article
public maryam hashemi
Isfahan Hezar Jerib Street
isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 7860 maryam.hashemi@med.mui.ac.ir Esfahan University of Medical Sciences scientific maryam hashemi
Isfahan Hezar Jerib St., Isfahan University of Medical Sciences
isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 7860 maryam.hashemi@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Women between 18 and 45 years old who are candidates for hysteroscopic myomectomy due to a symptomatic Figo submucosal myoma. The size of myoma should be less than 5 cm and the number of myoma should be one 18 years 45 years Female Women who have more than one myoma and myoma other than type 1. Women who have servicitis and are pregnant. D25.0 Submucous leiomyoma of uterus Treatment - Surgery Intervention group: women with submucousal myoma Fig. 1 During the shaving of the myoma with a resectoscope, the resectoscopy is stopped as soon as the pseudocapsule is reached and the pseudocapsule is kept in place .Three months after the operation using Doppler ultrasound, scar thickness, scar vascularity And the existence of a heterogeneous mass in the operation site is checked. Examination of myomectomy scar. Timepoint: 3 months after the operation. Method of measurement: Transvaginal ultrasound. Esfahan University of Medical Sciences Approved 2023-05-17 کمیته اخلاق دانشگاه علوم پزشکی اصفهان Isfahan Hezar Jerib St. Isfahan University of Medical Sciences and Health Services Isfahan Isfehan Iran (Islamic Republic of)