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

Endometriosis Clinical Trial

— EASLETE  

Official title:

Efficacy of Aspiration and Sclerotherapy During Laparoscopy Using 95% Ethanol for the Treatment of Endometriomas - a Prospective Case Control Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02472873
• Other study ID #: 0062-15
• Status: Enrolling by invitation
• Phase: N/A
• First received: June 7, 2015
• Last updated: June 15, 2015
• Start date: June 2015
• Est. completion date: June 2019

Study information

• Verified date: June 2015
• Source: Meir Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy of aspiration and sclerotherapy during laparoscopy using 95% ethanol for the treatment of endometriomas, compared to the standard cystectomy treatment - a prospective case control study.

Description:

Women who are candidates for elective laparoscopy for the treatment of ovarian ensometriomas will be assigned to one of two groups - a) standard cystectomy treatment, b) aspiration and sclerotherapy using 95% ethanol. The women will be introduced with both operative options and they will choose which one they prefer. 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), AFC (Antral Follicle Count), symptoms related to endometriosis (through a questionnaire), fertility history including any fertility treatment in the past and planned pregnancy after the operation.

The laparoscopy will take place in Meir Medical Center. 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 foley catheter. Ethanol will be left in the cyst for a maximum of 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 4 and 6 months after the surgery.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 120
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• women with endometrial cyst = 4 cm.

• candidates for elective laparoscopy due to endometriosis.

• age 18-45 years

Exclusion Criteria:

• endometrial cyst < 4 cm.

• an emergency surgery.

• age <18 or >45

• women with a history of tubal ovarian abscess (TOA).

• high index of suspision for ovarian malignancy.

• ethanol sensitivity.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometrioma
• Endometriosis

Intervention

Procedure:
• Aspiration and Sclerotherapy of endometriomas.
Aspiration and Sclerotherapy During Laparoscopy Using 95% Ethanol for the Treatment of Endometriomas
• cystectomy of endometriomas.
cystectomy of endometriomas during laparoscopy

Drug:
• Ethanol

Locations

Country	Name	City	State
Israel	Meir medical center	Kfar Saba

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (12)

Akamatsu N, Hirai T, Masaoka H, Sekiba K, Fujita T. [Ultrasonically guided puncture of endometrial cysts--aspiration of contents and infusion of ethanol]. Nihon Sanka Fujinka Gakkai Zasshi. 1988 Feb;40(2):187-91. Japanese. — View Citation

Bret PM, Atri M, Guibaud L, Gillett P, Seymour RJ, Senterman MK. Ovarian cysts in postmenopausal women: preliminary results with transvaginal alcohol sclerosis. Work in progress. Radiology. 1992 Sep;184(3):661-3. — View Citation

Busacca M, Chiaffarino F, Candiani M, Vignali M, Bertulessi C, Oggioni G, Parazzini F. Determinants of long-term clinically detected recurrence rates of deep, ovarian, and pelvic endometriosis. Am J Obstet Gynecol. 2006 Aug;195(2):426-32. — View Citation

Chapron C, Vercellini P, Barakat H, Vieira M, Dubuisson JB. Management of ovarian endometriomas. Hum Reprod Update. 2002 Nov-Dec;8(6):591-7. Review. — View Citation

Hsieh CL, Shiau CS, Lo LM, Hsieh TT, Chang MY. Effectiveness of ultrasound-guided aspiration and sclerotherapy with 95% ethanol for treatment of recurrent ovarian endometriomas. Fertil Steril. 2009 Jun;91(6):2709-13. doi: 10.1016/j.fertnstert.2008.03.056. Epub 2008 Jun 20. — View Citation

Kafali H, Yurtseven S, Atmaca F, Ozardali I. Management of non-neoplastic ovarian cysts with sclerotherapy. Int J Gynaecol Obstet. 2003 Apr;81(1):41-5. — View Citation

Koike T, Minakami H, Motoyama M, Ogawa S, Fujiwara H, Sato I. Reproductive performance after ultrasound-guided transvaginal ethanol sclerotherapy for ovarian endometriotic cysts. Eur J Obstet Gynecol Reprod Biol. 2002 Oct 10;105(1):39. — View Citation

Noma J, Yoshida N. Efficacy of ethanol sclerotherapy for ovarian endometriomas. Int J Gynaecol Obstet. 2001 Jan;72(1):35-9. — View Citation

Shaw RW. Treatment of endometriosis. Lancet. 1992 Nov 21;340(8830):1267-71. Review. — View Citation

Suganuma N, Wakahara Y, Ishida D, Asano M, Kitagawa T, Katsumata Y, Moriwaki T, Furuhashi M. Pretreatment for ovarian endometrial cyst before in vitro fertilization. Gynecol Obstet Invest. 2002;54 Suppl 1:36-40; discussion 41-2. Review. — View Citation

Takuma N, Sengoku K, Pan B, Wada K, Yamauchi T, Miyamoto T, Ohsumi D, Ishikawa M. Laparoscopic treatment of endometrioma-associated infertility and pregnancy outcome. Gynecol Obstet Invest. 2002;54 Suppl 1:30-4; discussion 34-5. — View Citation

Zanetta G, Lissoni A, Dalla Valle C, Trio D, Pittelli M, Rangoni G. Ultrasound-guided aspiration of endometriomas: possible applications and limitations. Fertil Steril. 1995 Oct;64(4):709-13. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	endometrioma recurrence rate	Ultrasound examination that demonstrate the presence/lack of ovarian cyst with sonographic features of endometrioma in the ovary where the sclerotherapy took place.	up to 6 months after the laparoscopy	No
Secondary	length of surgery	the time from insertion of the first trocar until closing of the abdominal wall.	intraoperative	No
Secondary	length of hospital stay		participants will be followed for the duration of hospital stay, an expected average of 2 days	No
Secondary	complication rate	infection, excessive bleeding, injury to other abdominal organs	during the surgery and until one month after the surgery.	No
Secondary	Measure of efficacy of the treatment by questionnaire		4 months and 6 months after the laparoscopy	No
Secondary	Ovarian reserve	Anti mullerian hormone (AMH) and antral follicle count (AFC) measurement 4 months and 6 months after the laparoscopy	4 months and 6 months after the laparoscopy	No