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

Primary Purpose

Endometrioma, Endometriosis

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Aspiration and Sclerotherapy of endometriomas.
cystectomy of endometriomas.
Ethanol
Sponsored by
Meir Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometrioma focused on measuring endometrioma, endometriosis, sclerotherapy, ethanol, aspiration, laparoscopy

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Meir medical center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

study group - sclerotherapy

control group - cystectomy

Arm Description

Aspiration and Sclerotherapy of endometriomas.

cystectomy of endometriomas.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

length of surgery
the time from insertion of the first trocar until closing of the abdominal wall.
length of hospital stay
complication rate
infection, excessive bleeding, injury to other abdominal organs
Measure of efficacy of the treatment by questionnaire
Ovarian reserve
Anti mullerian hormone (AMH) and antral follicle count (AFC) measurement 4 months and 6 months after the laparoscopy

Full Information

First Posted
June 7, 2015
Last Updated
June 15, 2015
Sponsor
Meir Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02472873
Brief Title
Efficacy of Aspiration and Sclerotherapy During Laparoscopy Using 95% Ethanol for the Treatment of Endometriomas
Acronym
EASLETE
Official Title
Efficacy of Aspiration and Sclerotherapy During Laparoscopy Using 95% Ethanol for the Treatment of Endometriomas - a Prospective Case Control Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (undefined)
Primary Completion Date
June 2019 (Anticipated)
Study Completion Date
June 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Meir Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrioma, Endometriosis
Keywords
endometrioma, endometriosis, sclerotherapy, ethanol, aspiration, laparoscopy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
study group - sclerotherapy
Arm Type
Experimental
Arm Description
Aspiration and Sclerotherapy of endometriomas.
Arm Title
control group - cystectomy
Arm Type
Other
Arm Description
cystectomy of endometriomas.
Intervention Type
Procedure
Intervention Name(s)
Aspiration and Sclerotherapy of endometriomas.
Intervention Description
Aspiration and Sclerotherapy During Laparoscopy Using 95% Ethanol for the Treatment of Endometriomas
Intervention Type
Procedure
Intervention Name(s)
cystectomy of endometriomas.
Intervention Description
cystectomy of endometriomas during laparoscopy
Intervention Type
Drug
Intervention Name(s)
Ethanol
Primary Outcome Measure Information:
Title
endometrioma recurrence rate
Description
Ultrasound examination that demonstrate the presence/lack of ovarian cyst with sonographic features of endometrioma in the ovary where the sclerotherapy took place.
Time Frame
up to 6 months after the laparoscopy
Secondary Outcome Measure Information:
Title
length of surgery
Description
the time from insertion of the first trocar until closing of the abdominal wall.
Time Frame
intraoperative
Title
length of hospital stay
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 2 days
Title
complication rate
Description
infection, excessive bleeding, injury to other abdominal organs
Time Frame
during the surgery and until one month after the surgery.
Title
Measure of efficacy of the treatment by questionnaire
Time Frame
4 months and 6 months after the laparoscopy
Title
Ovarian reserve
Description
Anti mullerian hormone (AMH) and antral follicle count (AFC) measurement 4 months and 6 months after the laparoscopy
Time Frame
4 months and 6 months after the laparoscopy

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dana Josephy, MD
Organizational Affiliation
Meir Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Meir medical center
City
Kfar Saba
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
12270563
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. doi: 10.1016/s0301-2115(02)00144-6.
Results Reference
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PubMed Identifier
12441659
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. doi: 10.1159/000066293.
Results Reference
background
PubMed Identifier
12498427
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. doi: 10.1093/humupd/8.6.591.
Results Reference
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PubMed Identifier
1359330
Citation
Shaw RW. Treatment of endometriosis. Lancet. 1992 Nov 21;340(8830):1267-71. doi: 10.1016/0140-6736(92)92960-n. No abstract available.
Results Reference
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PubMed Identifier
16890551
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. doi: 10.1016/j.ajog.2006.01.078.
Results Reference
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PubMed Identifier
7672139
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. doi: 10.1016/s0015-0282(16)57843-1.
Results Reference
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PubMed Identifier
3283269
Citation
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.
Results Reference
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PubMed Identifier
12676392
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. doi: 10.1016/s0020-7292(02)00401-0.
Results Reference
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PubMed Identifier
1509048
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. doi: 10.1148/radiology.184.3.1509048.
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11146075
Citation
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.
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PubMed Identifier
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Citation
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Citation
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Results Reference
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Efficacy of Aspiration and Sclerotherapy During Laparoscopy Using 95% Ethanol for the Treatment of Endometriomas

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