Comparison of Laparoscopic Endometrioma Stripping Versus Ethanol Sclerotherapy( CLESS)

Catholic University of the Sacred Heart

Status: Unknown

Conditions: Endometrioma

Treatments: Procedure: ethanol sclerotherapy; Procedure: stripping technique

Study type: Interventional

Funder types: Other

Identifiers

NCT04178876

2690

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 64 estimated patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

Aspiration and Sclerotherapy of endometriomas

Experimental group

Description:

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

Treatment:

Procedure: ethanol sclerotherapy

laparoscopic stripping technique

Active Comparator group

Description:

cystectomy of endometriomas during laparoscopy

Treatment:

Procedure: stripping technique