Comparison of Laparoscopic Endometrioma Stripping Versus Ethanol Sclerotherapy( CLESS)

NCT ID: NCT04178876

Last Updated: 2019-12-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-13
• Study Completion Date: 2023-06-01

Brief 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.

Detailed 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.

Conditions

Endometrioma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Aspiration and Sclerotherapy of endometriomas

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

Group Type: EXPERIMENTAL

ethanol sclerotherapy

Intervention Type: PROCEDURE

Endometrioma laparoscopic aspiration and sclerotherapy using 95% ethanol

laparoscopic stripping technique

cystectomy of endometriomas during laparoscopy

Group Type: ACTIVE_COMPARATOR

stripping technique

Intervention Type: PROCEDURE

Endometrioma laparoscopic cystectomy

Interventions

ethanol sclerotherapy

Endometrioma laparoscopic aspiration and sclerotherapy using 95% ethanol

Intervention Type: PROCEDURE

stripping technique

Endometrioma laparoscopic cystectomy

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Catholic University of the Sacred Heart

OTHER

Sponsor Role: lead

Responsible Party

Prof. Giovanni Scambia

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Giovanni Scambia, MD

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Gemelli, IRCSS Università Cattolica del Sacro Cuore, Roma

Locations

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Alessandra De Cicco Nardone, MD

Role: CONTACT

alessandradecicco@gmail.com

+393428235829

Facility Contacts

Alessandra De Cicco Nardone, MD

Role: primary

alessandradecicco@gmail.com

References

Sweed MS, Makled AK, El-Sayed MA, Shawky ME, Abd-Elhady HA, Mansour AM, Mohamed RM, Hemeda H, Nasr-Eldin EA, Attia NS, Eltaieb E, Allam H, Hussein A. Ovarian Reserve Following Laparoscopic Ovarian Cystectomy vs Cyst Deroofing for Endometriomas. J Minim Invasive Gynecol. 2019 Jul-Aug;26(5):877-882. doi: 10.1016/j.jmig.2018.06.022. Epub 2018 Sep 5.

Reference Type: BACKGROUND

PMID: 30193971 (View on PubMed)

Cohen A, Almog B, Tulandi T. Sclerotherapy in the management of ovarian endometrioma: systematic review and meta-analysis. Fertil Steril. 2017 Jul;108(1):117-124.e5. doi: 10.1016/j.fertnstert.2017.05.015. Epub 2017 Jun 1.

Reference Type: BACKGROUND

PMID: 28579409 (View on PubMed)

Messalli EM, Cobellis G, Pecori E, Pierno G, Scaffa C, Stradella L, Cobellis L. Alcohol sclerosis of endometriomas after ultrasound-guided aspiration. Minerva Ginecol. 2003 Aug;55(4):359-62.

Reference Type: BACKGROUND

PMID: 14581861 (View on PubMed)

Garcia-Tejedor A, Castellarnau M, Ponce J, Fernandez ME, Burdio F. Ethanol sclerotherapy of ovarian endometrioma: a safe and effective minimal invasive procedure. Preliminary results. Eur J Obstet Gynecol Reprod Biol. 2015 Apr;187:25-9. doi: 10.1016/j.ejogrb.2015.02.004. Epub 2015 Feb 16.

Reference Type: BACKGROUND

PMID: 25739052 (View on PubMed)

Kovacevic VM, Andelic LM, Mitrovic Jovanovic A. Changes in serum antimullerian hormone levels in patients 6 and 12 months after endometrioma stripping surgery. Fertil Steril. 2018 Nov;110(6):1173-1180. doi: 10.1016/j.fertnstert.2018.07.019.

Reference Type: BACKGROUND

PMID: 30396562 (View on PubMed)

Other Identifiers

2690

Identifier Type: -

Identifier Source: org_study_id