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 score≥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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
64
Endometrioma laparoscopic aspiration and sclerotherapy using 95% ethanol
Endometrioma laparoscopic cystectomy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy
RECRUITINGimpact on ovarian reserve, in terms of reduction of serum AMH levels
The AMH levels will be evaluated 1 month before the surgery and 1, 6 and 12 months after surgery.
Time frame: up to 12 months after the laparoscopy
endometrioma recurrence rate for the two surgical techniques
Ultrasound examination that demonstrate the presence/lack of ovarian cyst with sonographic features of endometrioma in the ovary where the procedure took place.
Time frame: up to 12 months after the laparoscopy
pain relief after surgery
The severity of pelvic pain , assessed using a visual analogue scale with no-pain classified as 0 and worst imaginable pain as 10.
Time frame: up to 12 months after the laparoscopy
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