Efficacy of Aspiration and Sclerotherapy During Laparoscopy Using 95% Ethanol for the Treatment of Endometriomas
NCT ID: NCT02472873
Last Updated: 2015-06-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
120 participants
INTERVENTIONAL
2015-06-30
2019-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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study group - sclerotherapy
Aspiration and Sclerotherapy of endometriomas.
Aspiration and Sclerotherapy of endometriomas.
Aspiration and Sclerotherapy During Laparoscopy Using 95% Ethanol for the Treatment of Endometriomas
Ethanol
control group - cystectomy
cystectomy of endometriomas.
cystectomy of endometriomas.
cystectomy of endometriomas during laparoscopy
Interventions
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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
Ethanol
Eligibility Criteria
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Inclusion Criteria
* candidates for elective laparoscopy due to endometriosis.
* age 18-45 years
Exclusion Criteria
* 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.
18 Years
45 Years
FEMALE
No
Sponsors
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Meir Medical Center
OTHER
Responsible Party
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Dana Josephy
Dr.
Principal Investigators
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Dana Josephy, MD
Role: PRINCIPAL_INVESTIGATOR
Meir Medical Center
Locations
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Meir medical center
Kfar Saba, , Israel
Countries
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References
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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. doi: 10.1016/s0301-2115(02)00144-6.
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. doi: 10.1159/000066293.
Chapron C, Vercellini P, Barakat H, Vieira M, Dubuisson JB. Management of ovarian endometriomas. Hum Reprod Update. 2002 Nov-Dec;8(6):591-7. doi: 10.1093/humupd/8.6.591.
Shaw RW. Treatment of endometriosis. Lancet. 1992 Nov 21;340(8830):1267-71. doi: 10.1016/0140-6736(92)92960-n. No abstract available.
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. doi: 10.1016/j.ajog.2006.01.078.
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. doi: 10.1016/s0015-0282(16)57843-1.
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.
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. doi: 10.1016/s0020-7292(02)00401-0.
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. doi: 10.1148/radiology.184.3.1509048.
Noma J, Yoshida N. Efficacy of ethanol sclerotherapy for ovarian endometriomas. Int J Gynaecol Obstet. 2001 Jan;72(1):35-9. doi: 10.1016/s0020-7292(00)00307-6.
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.
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. doi: 10.1159/000066292.
Other Identifiers
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0062-15
Identifier Type: -
Identifier Source: org_study_id
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