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IRCT20200825048515N19 IRCT 2021-01-03 Esfahan University of Medical Sciences Evaluation of the efficacy and complications of uterine artery embolization with laparotomy myomectomy in the treatment of uterine fibroids Evaluation of the efficacy and complications of uterine artery embolization with laparotomy myomectomy in the treatment of uterine fibroids 2020-12-21 anticipated 80 Complete https://irct.ir/trial/52891 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, 80 eligible patients will be randomly selected. Then, these patients will be randomly encoded using computer software called "Random Allocation" and automatically divided into two groups. The relevant codes will be entered in the raw checklists and each of these checklists will be randomly assigned to one patient and that patient will be randomly assigned to one of the two study groups, Blinding description: In this study, due to differences in surgery, the researcher is aware of the types of treatment for the two groups. However, the patient due to the lack of consciousness and the person evaluating the patient's hemodynamic parameters and the data analyst, will not have any information about the two groups. 2 Uterine Myoma. Intervention 1: Intervention group 1: Patients in this group undergo myomectomy. In this method, the patient is hospitalized the night before the operation and receives intestinal operation preparation. He fasts from 12 o'clock at night and receives serum. And prepares for laparotomy myomectomy and after preparation, undergoes laparotomy myomectomy. Intervention 2: Intervention group 2: Patients in this group undergo uterine artery embolization. In this method, the patient goes to the angiography department on an empty stomach and submits the results of the tests he performed the day before, along with an ECG and an image of the lungs (which are necessary for the operation) to the secretary of the angiography department. After verification of the records, the patient is prepared for injection and the anesthetist injects the patient with the necessary amount of sedative. The area of ​​the body where the catheter is to be inserted is repaired and disinfected and the surgical bag is covered. Next, the catheter entry site, which is usually the groin, is anesthetized. The catheter then enters the artery under the guidance of an X-ray and is placed in the groin area. The blocker substance is then released in turn into the right and left uterine arteries. In the end, only a small hole remains on the skin. Finally, the catheter is removed from the artery and the pressure is taken to prevent bleeding from the perforated area. In this method, there is no need for sutures and the patient can be discharged if the clinical condition stabilizes. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Zahra Allameh
Department of Obstetrics and Gynecology, Al-Zahra Hospital, Sofeh Blvd., Tohid Street
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 z-allameh@med.mui.ac.ir Esfahan University of Medical Sciences scientific Zahra Allameh
Department of Obstetrics and Gynecology, Al-Zahra Hospital, Sofeh Blvd., Tohid Street
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 z-allameh@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Consent to participant in the study Aged between 30 and 45 years old Completion of fertility and unwillingness to fertility Diagnosis of symptomatic uterine myoma without response to supportive measures 30 years 45 years Female Suspected malignancy based on medical imaging Failure to perform previous endometrial biopsy to rule out malignancy Pregnancy Acute pelvic inflammatory disease Sensitivity to contrast medium D25.9 Leiomyoma of uterus, unspecified Treatment - Surgery Treatment - Surgery Intervention group 1: Patients in this group undergo myomectomy. In this method, the patient is hospitalized the night before the operation and receives intestinal operation preparation. He fasts from 12 o'clock at night and receives serum. And prepares for laparotomy myomectomy and after preparation, undergoes laparotomy myomectomy. Intervention group 2: Patients in this group undergo uterine artery embolization. In this method, the patient goes to the angiography department on an empty stomach and submits the results of the tests he performed the day before, along with an ECG and an image of the lungs (which are necessary for the operation) to the secretary of the angiography department. After verification of the records, the patient is prepared for injection and the anesthetist injects the patient with the necessary amount of sedative. The area of ​​the body where the catheter is to be inserted is repaired and disinfected and the surgical bag is covered. Next, the catheter entry site, which is usually the groin, is anesthetized. The catheter then enters the artery under the guidance of an X-ray and is placed in the groin area. The blocker substance is then released in turn into the right and left uterine arteries. In the end, only a small hole remains on the skin. Finally, the catheter is removed from the artery and the pressure is taken to prevent bleeding from the perforated area. In this method, there is no need for sutures and the patient can be discharged if the clinical condition stabilizes. Pain score. Timepoint: 10 days, two months, six months, and twelve months after surgery. Method of measurement: Visual Analog Scale (VAS). Bleeding. Timepoint: 10 days, two months, six months, and twelve months after surgery. Method of measurement: Observation. Hemoglobin. Timepoint: 10 days, two months, six months, and twelve months after surgery. Method of measurement: Blood test. Isfahan University of Medical Sciences Approved 2019-10-09 Ethics committee of Isfahan University of Medical Sciences Street address Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq Isfahan Isfehan Iran (Islamic Republic of)