Comparison of Laparoscopic Endometrioma Stripping Versus Ethanol Sclerotherapy( CLESS) (CLESS)

  • STATUS
    Recruiting
  • End date
    Jun 1, 2023
  • participants needed
    64
  • sponsor
    Catholic University of the Sacred Heart
Updated on 19 February 2022
aspiration
laparoscopy
dysmenorrhea
pelvic pain
endometrioma
anti-mullerian hormone

Summary

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.

Description

Patients with pelvic pain (VAS score4) 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.

Details
Condition Endometrioma
Treatment stripping technique, ethanol sclerotherapy
Clinical Study IdentifierNCT04178876
SponsorCatholic University of the Sacred Heart
Last Modified on19 February 2022

Eligibility

Yes No Not Sure

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
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