The purpose of this study is to evaluate the efficacy of aspiration and sclerotherapy during laparoscopy using 95% ethanol for the treatment of endometriomas, compared to the standard cystectomy treatment - a prospective case control study.
Women who are candidates for elective laparoscopy for the treatment of ovarian ensometriomas will be assigned to one of two groups - a) standard cystectomy treatment, b) aspiration and sclerotherapy using 95% ethanol. The women will be introduced with both operative options and they will choose which one they prefer. After an elaborate explanation about the study they will sign an informed consent form. the following data will be collected prior the operation: age, gravity \& parity, operative history, general medical history, the cyst size, AMH (Anti Mullerian Hormone), AFC (Antral Follicle Count), symptoms related to endometriosis (through a questionnaire), fertility history including any fertility treatment in the past and planned pregnancy after the operation. The laparoscopy will take place in Meir Medical Center. in the study group the cyst content will be aspirated and flushed with normal saline. 95% sterile ethanol will be instilled into the cyst through a foley catheter. Ethanol will be left in the cyst for a maximum of 15 min then aspirated as completely as possible following normal saline flushing. In the control group we will follow the standard treatment which is cystectomy. The women will be followed 4 and 6 months after the surgery.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Aspiration and Sclerotherapy During Laparoscopy Using 95% Ethanol for the Treatment of Endometriomas
cystectomy of endometriomas during laparoscopy
Meir medical center
Kfar Saba, Israel
endometrioma recurrence rate
Ultrasound examination that demonstrate the presence/lack of ovarian cyst with sonographic features of endometrioma in the ovary where the sclerotherapy took place.
Time frame: up to 6 months after the laparoscopy
length of surgery
the time from insertion of the first trocar until closing of the abdominal wall.
Time frame: intraoperative
length of hospital stay
Time frame: participants will be followed for the duration of hospital stay, an expected average of 2 days
complication rate
infection, excessive bleeding, injury to other abdominal organs
Time frame: during the surgery and until one month after the surgery.
Measure of efficacy of the treatment by questionnaire
Time frame: 4 months and 6 months after the laparoscopy
Ovarian reserve
Anti mullerian hormone (AMH) and antral follicle count (AFC) measurement 4 months and 6 months after the laparoscopy
Time frame: 4 months and 6 months after the laparoscopy
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