Comparison of Laparoscopic Endometrioma Stripping Versus Ethanol Sclerotherapy( CLESS)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparison of Laparoscopic Endometrioma Stripping Versus Ethanol Sclerotherapy: Impact on Ovarian Reserve.

Conditions
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Endometrioma

Intervention / Treatment
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* Procedure: ethanol sclerotherapy
* Procedure: stripping technique


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women between 18-35 years old Women with ultrasound diagnosis of ovarian endometrioma ≥4cm (with or without deep infiltrating endometriosis) History of dysmenorrhea and/or chronic pelvic pain candidates for elective laparoscopy due to endometriosis. Exclusion Criteria: - Previous surgery for ovarian endometriosis Evidence of premature ovarian failure (follicle stimulating hormone ≥40 international units/L) Endocrinal disorders that might affect ovarian function (e.g., polycystic ovary syndrome, thyroid dysfunction, hyperprolactinemia) Ultrasound suspicious of ovarian malignant disease according IOTA criteria endometrial cyst < 4 cm. • ethanol sensitivity.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aspiration and Sclerotherapy of endometriomas<br>Aspiration and Sclerotherapy During Laparoscopy Using 95% Ethanol for the Treatment of Endometriomas | Procedure: ethanol sclerotherapy<br>* Endometrioma laparoscopic aspiration and sclerotherapy using 95% ethanol<br>|
| Active Comparator: laparoscopic stripping technique<br>cystectomy of endometriomas during laparoscopy | Procedure: stripping technique<br>* Endometrioma laparoscopic cystectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| impact 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. | up to 12 months after the laparoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | up to 12 months after the laparoscopy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endometrioma, ethanol, sclerotherapy, aspiration, ovarian reserve, endometriosis, AMH