Efficacy of Aspiration and Sclerotherapy During Laparoscopy Using 95% Ethanol for the Treatment of Endometriomas

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Efficacy of Aspiration and Sclerotherapy During Laparoscopy Using 95% Ethanol for the Treatment of Endometriomas - a Prospective Case Control Study

Conditions
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Endometrioma, Endometriosis

Intervention / Treatment
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* Procedure: Aspiration and Sclerotherapy of endometriomas.
* Procedure: cystectomy of endometriomas.
* Drug: Ethanol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women with endometrial cyst ≥ 4 cm. candidates for elective laparoscopy due to endometriosis. age 18-45 years Exclusion Criteria: endometrial cyst < 4 cm. an emergency surgery. age <18 or >45 women with a history of tubal ovarian abscess (TOA). high index of suspision for ovarian malignancy. ethanol sensitivity.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: study group - sclerotherapy<br>Aspiration and Sclerotherapy of endometriomas. | Procedure: Aspiration and Sclerotherapy of endometriomas.<br>* Aspiration and Sclerotherapy During Laparoscopy Using 95% Ethanol for the Treatment of Endometriomas<br>Drug: Ethanol<br> <br> |
| Other: control group - cystectomy<br>cystectomy of endometriomas. | Procedure: cystectomy of endometriomas.<br>* cystectomy of endometriomas during laparoscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | up to 6 months after the laparoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of surgery | the time from insertion of the first trocar until closing of the abdominal wall. | intraoperative | 
| length of hospital stay |  | 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 | during the surgery and until one month after the surgery. | 
| Measure of efficacy of the treatment by questionnaire |  | 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 | 4 months and 6 months after the laparoscopy | 

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