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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aspiration and Sclerotherapy of endometriomas | Experimental | Aspiration and Sclerotherapy During Laparoscopy Using 95% Ethanol for the Treatment of Endometriomas |
|
| laparoscopic stripping technique | Active Comparator | cystectomy of endometriomas during laparoscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ethanol sclerotherapy | Procedure | Endometrioma laparoscopic aspiration and sclerotherapy using 95% ethanol |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| pain relief after surgery |
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Inclusion Criteria:
Exclusion Criteria:
This is a Gynecological study
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alessandra De Cicco Nardone, MD | Contact | +393428235829 | alessandradecicco@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Giovanni Scambia, MD | Fondazione Policlinico Gemelli, IRCSS Università Cattolica del Sacro Cuore, Roma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Recruiting | Roma | 00168 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30193971 | Background | 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. | |
| 28579409 |
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Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
data will become available following publication.
To gain access, data requestors will need to sign a data access agreement.
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| stripping technique | Procedure | Endometrioma laparoscopic cystectomy |
|
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 |
| 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. |
| 14581861 | Background | 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. |
| 25739052 | Background | 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. |
| 30396562 | Background | 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. |
| D000091662 | Genital Diseases |