Endometrioma, Endometriosis
Conditions
Keywords
endometrioma, endometriosis, sclerotherapy, ethanol, aspiration, laparoscopy
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.
Interventions
PROCEDUREAspiration and Sclerotherapy of endometriomas.
Aspiration and Sclerotherapy During Laparoscopy Using 95% Ethanol for the Treatment of Endometriomas
PROCEDUREcystectomy of endometriomas.
cystectomy of endometriomas during laparoscopy
DRUGEthanol
Sponsors
Meir Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| length of surgery | intraoperative | the time from insertion of the first trocar until closing of the abdominal wall. |
| length of hospital stay | participants will be followed for the duration of hospital stay, an expected average of 2 days | — |
| complication rate | during the surgery and until one month after the surgery. | infection, excessive bleeding, injury to other abdominal organs |
| Measure of efficacy of the treatment by questionnaire | 4 months and 6 months after the laparoscopy | — |
| 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 |
Countries
Israel
Outcome results
None listed