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

Clalit Health Services

Status: Unknown

Conditions: Endometriosis; Endometrioma

Treatments: Procedure: cystectomy of endometriomas.; Procedure: Aspiration and Sclerotherapy of endometriomas.; Drug: Ethanol

Study type: Interventional

Funder types: Other

Identifiers

NCT02472873

0062-15

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

study group - sclerotherapy

Experimental group

Description:

Aspiration and Sclerotherapy of endometriomas.

Treatment:

Procedure: Aspiration and Sclerotherapy of endometriomas.

Drug: Ethanol

control group - cystectomy

Other group

Description:

cystectomy of endometriomas.

Treatment:

Procedure: cystectomy of endometriomas.