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IRCT20200408046993N2 IRCT 2020-05-26 Yazd University of Medical Sciences The effect of total cystectomy surgery versus parietal cystectomy on the ovarian reservation Evaluation of Ovarian Reservation in Women with Endometriosis under Total Cystectomy Compared to Partial Cystectomy 2020-01-14 anticipated 56 Complete https://irct.ir/trial/47165 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, in people before surgery, the concentration of antimullerin hormone is measured by ELISA method and after grouping endometriosis in them, by using simple randomization method with individual unit and by using the table of random numbers of people in The two groups of partial and total cystectomy are operated on, and all patients are operated on by one surgeon to minimize the difference in surgical technique. 3 Endometriosis. Intervention 1: Intervention group 1: In this group, total cystectomy surgery was performed in which patients underwent general anesthesia and endotracheal intubation in 30 degree Thunderrenberg condition and lithotomy, and carbon dioxide gas was opened by a 10 mm trocar with open method And 10 mm Hg pressure and under the supervision of a 10 mm rigid laparoscope inserted through the umbilical port and 2 other 5 mm ports created 2 cm above the iliac bone and a uterine manipulator placed inside the patient's uterus. If necessary, the Keldosak area was released, then the cyst was aspirated and emptied, and the adhesion between the cyst and the pelvic wall was released, and then the internal wall of the cyst was gently separated from the normal ovarian cortex by two atromatic pliers. In all patients, the presence of endometriosis was confirmed by pathology, and the antimullerin levels of the hormone were examined before and 3 months after the operation. Intervention 2: Intervention group 2: In this group, partial cystectomy surgery was performed. In this method, patients underwent general anesthesia and endotracheal intubation in 30 degree Thunderrenberg condition and in lithotomy status, and carbon dioxide gas by a 10 mm trocar with open method and pressure 10 mmHg under the supervision of a 10 mm rigid laparoscope inserted through the umbilical port, two other 5 mm ports created 2 cm above the iliac bone, and a uterine manipulator placed inside the patient's uterus. If necessary, the Keldosak area was released, then the cyst was aspirated and emptied, and the adhesion between the cyst and the pelvic wall was released. The umbilical cord remains the ovary. In all patients, the presence of endometriosis was confirmed by pathology, and the antimullerin levels of the hormone were examined before and 3 months after the operation. 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 There is no further information.
public Atiyeh Javaheri
Shahid Sadoughi hospital, Ebne- Sina Ave., Yazd, Iran
Yazd Iran (Islamic Republic of) 8915887857 +98 35 3822 4000 a.javaheri@ssu.ac.ir Yazd University of Medical Sciences scientific Atiyeh Javaheri
Shahid Sadoughi hospital, Ebne- Sina Ave., Yazd, Iran
Yazd Iran (Islamic Republic of) 8915887857 +98 35 3822 4000 a.javaheri@ssu.ac.ir Yazd University of Medical Sciences Iran (Islamic Republic of) Age between 20 to 40 years old Serum level of anti-Müllerian hormone (AMH) over than 1 ng/mL ٍEndometrioma cyst larger than 4 cm 20 years 40 years Female Pregnancy Menstrual bleeding disorder Endocrine disorders include thyroid disorder, hyperprolactinemia, or Cushing's syndrome History of ovarian surgery and surgeries that have altered the anatomy of the pelvic cavity The serum level of follicle stimulating hormone (FSH) around menopause Suspicion of ovarian malignancies Take oral contraceptive pills (OCPs) three months before surgery N80.1 Endometriosis of ovary Treatment - Surgery Treatment - Surgery Intervention group 1: In this group, total cystectomy surgery was performed in which patients underwent general anesthesia and endotracheal intubation in 30 degree Thunderrenberg condition and lithotomy, and carbon dioxide gas was opened by a 10 mm trocar with open method And 10 mm Hg pressure and under the supervision of a 10 mm rigid laparoscope inserted through the umbilical port and 2 other 5 mm ports created 2 cm above the iliac bone and a uterine manipulator placed inside the patient's uterus. If necessary, the Keldosak area was released, then the cyst was aspirated and emptied, and the adhesion between the cyst and the pelvic wall was released, and then the internal wall of the cyst was gently separated from the normal ovarian cortex by two atromatic pliers. In all patients, the presence of endometriosis was confirmed by pathology, and the antimullerin levels of the hormone were examined before and 3 months after the operation. Intervention group 2: In this group, partial cystectomy surgery was performed. In this method, patients underwent general anesthesia and endotracheal intubation in 30 degree Thunderrenberg condition and in lithotomy status, and carbon dioxide gas by a 10 mm trocar with open method and pressure 10 mmHg under the supervision of a 10 mm rigid laparoscope inserted through the umbilical port, two other 5 mm ports created 2 cm above the iliac bone, and a uterine manipulator placed inside the patient's uterus. If necessary, the Keldosak area was released, then the cyst was aspirated and emptied, and the adhesion between the cyst and the pelvic wall was released. The umbilical cord remains the ovary. In all patients, the presence of endometriosis was confirmed by pathology, and the antimullerin levels of the hormone were examined before and 3 months after the operation. The serum level of anti-müllerian hormone. Timepoint: At the beginning of the study (Before intervention) and 3 months after the intervention (Cystectomy). Method of measurement: Eliza's method. The serum CA125 level. Timepoint: At the beginning of the study (Before intervention). Method of measurement: Eliza's method. Yazd University of Medical Sciences Approved 2020-01-14 Ethics committee of Yazd Shahid Sadoughi University of Medical Sciences School of Medicine, Shahid Sadoughi University of Medical Sciences, Shohaday-e-Gomnam Blvd., Alem Sq., Yazd, Iran Yazd Yazd Iran (Islamic Republic of)