Endometrioma Clinical Trial
Official title:
Comparison of Laparoscopic Endometrioma Stripping Versus Ethanol Sclerotherapy: Impact on Ovarian Reserve.
The aim of this study is to compare two different laparoscopic surgical techniques (endometrioma stripping vs ethanol sclerotherapy) in terms of ovarian reserve (AMH levels), recurrence rate and pain relief.
Patients with pelvic pain (VAS scoreā„4) and ultrasound diagnosis of endometrioma > 4cm
candidate to surgical removal of endometrioma will be randomized into 2 group. One Group will
undergo laparoscopical stripping technique; the other one will undergo laparoscopic
aspiration and sclerotherapy using 95% ethanol.
The women will be introduced with both operative options and they will be informed about the
randomization . 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), symptoms related to endometriosis (through VAS score), fertility history including
any fertility treatment in the past and planned pregnancy after the operation.
The laparoscopy will take place in Fondazione Policlinico Gemelli IRCSS, Roma. 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 Nelathon catheter. Ethanol will be left in the cyst
for 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 at 1 , 3 , 6 and 12 months after the surgery.
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