Comparison of Laparoscopic Endometrioma Stripping Versus Ethanol Sclerotherapy( CLESS)

Endometrioma Clinical Trial

— CLESS  

Official title:

Comparison of Laparoscopic Endometrioma Stripping Versus Ethanol Sclerotherapy: Impact on Ovarian Reserve.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04178876
• Other study ID #: 2690
• Status: Recruiting
• Phase: N/A
• Start date: September 13, 2019
• Est. completion date: June 1, 2023

Study information

• Verified date: December 2019
• Source: Catholic University of the Sacred Heart
• Contact: Alessandra De Cicco Nardone, MD
• Phone: +393428235829
• Email: alessandradecicco[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: June 1, 2023
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Endometrioma
• Endometriosis

Intervention

Procedure:
• ethanol sclerotherapy
Endometrioma laparoscopic aspiration and sclerotherapy using 95% ethanol
• stripping technique
Endometrioma laparoscopic cystectomy

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart

Country where clinical trial is conducted

Italy, 

References & Publications (5)

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. Review. — View Citation

García-Tejedor A, Castellarnau M, Ponce J, Fernández 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. — View Citation

Kovacevic VM, Andelic LM, Mitrovic Jovanovic A. Changes in serum antimüllerian 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	impact on ovarian reserve, in terms of reduction of serum AMH levels	The AMH levels will be evaluated 1 month before the surgery and 1, 6 and 12 months after surgery.	up to 12 months after the laparoscopy
Secondary	endometrioma recurrence rate for the two surgical techniques	Ultrasound examination that demonstrate the presence/lack of ovarian cyst with sonographic features of endometrioma in the ovary where the procedure took place.	up to 12 months after the laparoscopy
Secondary	pain relief after surgery	The severity of pelvic pain , assessed using a visual analogue scale with no-pain classified as 0 and worst imaginable pain as 10.	up to 12 months after the laparoscopy