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IRCT20150817023666N13 IRCT 2021-04-20 Iran University of Medical Sciences The effect of hydrodissection on antimullerian hormone (AMH) in laparoscopic endometrioma surgery Evaluation of the effect of hydrodissection with and without vasopressin on antimullerian hormone (AMH) in comparison with the usual method in laparoscopic endometrioma surgery: a double-blind clinical trial 2021-02-19 anticipated 15 Complete https://irct.ir/trial/54123 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random allocation in this study is limited to intervention and control groups using randomization. Random allocation law is the simplest and most limited method of randomization. This method represents a large block for the total sample size. For this purpose, the researchers first determine the total sample size and then randomly divide a set of them into groups A, B, C. For example, in this study with a sample size of 15 balls, 5 balls for intervention group A and 5 balls for intervention group B, and 5 balls for the control group (C) are placed inside a lottery bowl and then the balls are randomly removed from the container and removed. This method is used for two- or multi-group experiments, Blinding description: The outcome assessor and data analyst will not know how the groups are assigned. But because patients' consent must be obtained, the patient knows in which group. For this purpose, before random allocation, a complete explanation of the interventions is given and the patient is told that they will be randomly placed in one of the groups. 3 Women with endometrioma ovarian cysts. Intervention 1: Intervention group 1: Laparoscopic cystectomy for ovarian cyst surgery is performed by hydro dissection (50-70 ml of normal saline) in which hydrodissection is injected in several points of the cyst wall. Then the cyst wall is removed and for pathology The cyst bed is then checked for bleeding and, if necessary, an electrocautery is used for homeostasis. Intervention 2: Intervention group 2: Laparoscopic cystectomy for ovarian cyst surgery by hydro dissection; Hydrodissection method with vasopressin (Durvana company) in the intervention group, before starting to remove the wall of the cyst 3 ml, contains 0.3 units of an ampoule called vasopressin (Hypress) which contains 20 units and is diluted 200 times in 200 ml of normal saline solution It is inserted into the space between the walls of the ovarian cyst using a special needle, injected at one point of the cyst near the large vessels, followed by 50-70 ml of normal saline is injected at several points. The cyst wall is then removed and sent for pathology. The cyst bed is then checked for bleeding and, if necessary, an electrocautery is used for homeostasis. Intervention 3: Control group: Laparoscopic cystectomy for ovarian cyst surgery is performed in a simple and common way. It is a surgical procedure in which a light vision device (laparoscope) is inserted into the lower abdomen through a small incision, usually made under the umbilicus. Yes - There is a plan to make this available What will be shared: Part of data like the main outcome or the same will be shared When: Access after 6 months after publication To whom: Data will be available for all researchers Conditions: It can be used for further research and improvement of surgery. Surgeons and gynecologists can use this data. Where to obtain: For receiving data please be contacted with mehdizadeh.a@iums.ac.ir How to obtain: limitless Comments:
public Dr Abolfazl Mehdizadeh Kashi
Sattar Khan - Hazrat Rasool Akram Hospital
tehran Iran (Islamic Republic of) ۱۴۴۹۶۱۴۵۳۵ +98 21 6650 9283 mehdizadeh.a@iums.ac.ir Iran University of Medical Sciences scientific Abolfazl Mehdizadeh kashi
Hazrate Rasool Akram(s) Hospital
Tehran Iran (Islamic Republic of) ۱۴۴۹۶۱۴۵۳۵ +98 216651500 mehdizadeh.a@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Women of childbearing age are 18 to 35 years old. With endometrioma ovarian cysts less than 10 cm. Has unilateral ovarian cysts with a diameter of 4 to 10 cm that are confirmed by ultrasound. Have a body mass index between 19 and 30. Have not received hormonal drugs, especially GnRH agonists, in the last 3 months. 18 years 35 years Female Patients have unilateral ovarian cysts 4 -10 cm in diameter, which are confirmed by ultrasound sonography. Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group 1: Laparoscopic cystectomy for ovarian cyst surgery is performed by hydro dissection (50-70 ml of normal saline) in which hydrodissection is injected in several points of the cyst wall. Then the cyst wall is removed and for pathology The cyst bed is then checked for bleeding and, if necessary, an electrocautery is used for homeostasis. Intervention group 2: Laparoscopic cystectomy for ovarian cyst surgery by hydro dissection; Hydrodissection method with vasopressin (Durvana company) in the intervention group, before starting to remove the wall of the cyst 3 ml, contains 0.3 units of an ampoule called vasopressin (Hypress) which contains 20 units and is diluted 200 times in 200 ml of normal saline solution It is inserted into the space between the walls of the ovarian cyst using a special needle, injected at one point of the cyst near the large vessels, followed by 50-70 ml of normal saline is injected at several points. The cyst wall is then removed and sent for pathology. The cyst bed is then checked for bleeding and, if necessary, an electrocautery is used for homeostasis. Control group: Laparoscopic cystectomy for ovarian cyst surgery is performed in a simple and common way. It is a surgical procedure in which a light vision device (laparoscope) is inserted into the lower abdomen through a small incision, usually made under the umbilicus. Antimullerian Hormone changes in patients. Timepoint: Mean levels of Antimullerian Hormone in all patients before and after laparoscopic cystectomy. Method of measurement: Questionnaire and patient file. Hemoglobin changes in patients. Timepoint: Mean levels of hemoglobin in all patients before and after laparoscopic cystectomy. Method of measurement: Questionnaire and patient file. Iran University of Medical Sciences Approved 2020-10-21 Iran University Of Medical Sciences Sattar Khan - Hazrat Rasool Akram Hospital Tehran Tehran Iran (Islamic Republic of)