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

Not Applicable

• Conditions: Endometrioma; Endometriosis
• Interventions: Procedure: Aspiration and Sclerotherapy of endometriomas.; Procedure: cystectomy of endometriomas.; Drug: Ethanol

• Registration Number: NCT02472873
• Lead Sponsor: Meir Medical Center

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.

Study Timeline

• Status Verified: 2015-06
• Study Start: 2015-06
• Study First Submitted: 2015-06-07
• Study First Submitted QC: 2015-06-15
• Last Update Submitted: 2015-06-15
• Study First Posted: 2015-06-16
• Last Update Posted: 2015-06-16
• Primary Completion: 2019-06
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

• women with endometrial cyst ≥ 4 cm.
• candidates for elective laparoscopy due to endometriosis.
• age 18-45 years

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
study group - sclerotherapy	Ethanol	Aspiration and Sclerotherapy of endometriomas.
study group - sclerotherapy	Aspiration and Sclerotherapy of endometriomas.	Aspiration and Sclerotherapy of endometriomas.
control group - cystectomy	cystectomy of endometriomas.	cystectomy of endometriomas.

Primary Outcome Measures

Name	Time	Method
endometrioma recurrence rate	up to 6 months after the laparoscopy	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

Name	Time	Method
Measure of efficacy of the treatment by questionnaire	4 months and 6 months after the laparoscopy
length of hospital stay	participants will be followed for the duration of hospital stay, an expected average of 2 days
length of surgery	intraoperative	the time from insertion of the first trocar until closing of the abdominal wall.
complication rate	during the surgery and until one month after the surgery.	infection, excessive bleeding, injury to other abdominal organs
Ovarian reserve	4 months and 6 months after the laparoscopy	Anti mullerian hormone (AMH) and antral follicle count (AFC) measurement 4 months and 6 months after the laparoscopy

Trial Locations

Locations (1)

Meir medical center; 🇮🇱 Kfar Saba, Israel