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IRCT20220210053986N1 IRCT 2022-03-06 Iran University of Medical Sciences Comparison of Cavaterm endometrial ablation Vs. hysteroscopic endometrial ablation in treatment of abnormal uterine beeding Compare of Cavaterm endometrial ablation Vs. hysteroscopic endometrial ablation in treatment of abnormal uterine beeding 2019-09-23 anticipated 50 Complete https://irct.ir/trial/61890 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are randomly divided into two groups by simple randomization using Excel software and using the RAND function. A column of 100 numbers is created in Excel software containing 50 codes A (cavater group) and 50 codes B (hysteroscopic group). The parallel column contains one hundred random numbers will be generated by the RAND function. After arranging the randomized column while maintaining the connection to the first column, a random sequence is prepared and patients are divided into two groups, respectively. 3 Abnormla Uterine Bleeding. Intervention 1: Intervention group: Endometrial ablation by the Cavtherm thermal balloon method: The Cavaterm method is based on the rotation of hot water with a temperature of about 80 ° C at a constant pressure between 240-230 mm Hg in a silicon balloon for 10 minutes. The Cavaterm system consists of a disposable catheter with an adjustable silicone balloon and a central unit. 10 minute treatment is a combination of heat, circulation and also water pressure to coagulate the endometrium and its underlying myometrial layer in depth of 5 to 9 mm. Intervention 2: Control group: Endometrial ablation by hysteroscopic method: First in the operating room, after filling and emptying and emptying the bladder, uterus, adnexa, is determined by double-handed examination of the touch and position of the uterus. After venting the normal saline and white balance dilating media system with a 4.5 mm diagnostic hysteroscope, the uterine cavity was examined in all directions. In the absence of a problem, the lower valve of the vagina is inserted and the anterior edge of the cervix is ​​closed with a tenaculum, and uterine curettage is performed in all directions. After re-ventilation and performing white balance, it enters the endometrial cavity and the endometrial cavity is coagulated with a hysteroscope with a power of 50-150 watts, depending on the size of the electrode, depending on the size of the electrode and coagulation. The lateral and eventually the posterior wall is destroyed. In this method, during the destruction, it is activated only when the electrode moves towards the surgeon, at the same time, it tries to avoid the destruction of the cervical mucosa. 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 The study is a student thesis and its intellectual property is with Iran University of Medical Sciences.
public Sepideh Azizi
Akbarabadi hospital, Baghferdous station, Molavi st.
Tehran Iran (Islamic Republic of) 1168743514 +98 21 5560 6034 sepidehazizi.azizi@gmail.com Iran University of Medical Sciences scientific Mahdis Mohammadian
Akbarabadi hospital, Baghferdous station, Molavi st.
Tehran Iran (Islamic Republic of) 1168743514 +98 912 003 0255 Amiri_mahdis@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Non nullipar women in the age range between 35-55 Abnormal uterine bleeding (AUB) Lack of proper response to medical treatment Not trying to conceeve more Unwillingness to hystrectomy 35 years 55 years Female Malignancy which confirmed in pathology (Curretage or piple biopsy sample) Grade 0 & 1 submucosal myoma in sonography Uterine cavity distortion Uterine size > 20 weeks N93 Other abnormal uterine and vaginal bleeding Treatment - Surgery Treatment - Surgery Intervention group: Endometrial ablation by the Cavtherm thermal balloon method: The Cavaterm method is based on the rotation of hot water with a temperature of about 80 ° C at a constant pressure between 240-230 mm Hg in a silicon balloon for 10 minutes. The Cavaterm system consists of a disposable catheter with an adjustable silicone balloon and a central unit. 10 minute treatment is a combination of heat, circulation and also water pressure to coagulate the endometrium and its underlying myometrial layer in depth of 5 to 9 mm. Control group: Endometrial ablation by hysteroscopic method: First in the operating room, after filling and emptying and emptying the bladder, uterus, adnexa, is determined by double-handed examination of the touch and position of the uterus. After venting the normal saline and white balance dilating media system with a 4.5 mm diagnostic hysteroscope, the uterine cavity was examined in all directions. In the absence of a problem, the lower valve of the vagina is inserted and the anterior edge of the cervix is ​​closed with a tenaculum, and uterine curettage is performed in all directions. After re-ventilation and performing white balance, it enters the endometrial cavity and the endometrial cavity is coagulated with a hysteroscope with a power of 50-150 watts, depending on the size of the electrode, depending on the size of the electrode and coagulation. The lateral and eventually the posterior wall is destroyed. In this method, during the destruction, it is activated only when the electrode moves towards the surgeon, at the same time, it tries to avoid the destruction of the cervical mucosa. Amenorhea incidence. Timepoint: Months 3,6 and 12 after surgery. Method of measurement: Clinical history. Need to hystrectomy. Timepoint: Months 3, 6 and 12 after surgery. Method of measurement: Clinical history. Menstraul bleeding severity. Timepoint: Months 3,6 and 12 after surgery. Method of measurement: Days of menstraul bleeding and number of used menstrual pads. Satisfaction after surgery. Timepoint: Months 3,6 and 12 after surgery. Method of measurement: Likert scale. Iran University of Medical Sciences Approved 2019-12-29 Research Ethics Committee of School of Medicine, IUMS Hemmat exp.way Tehran Tehran Iran (Islamic Republic of)