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Patients undergoing elective laparoscopic ovarian cystectomy will be recruited and randomly divided into 2 groups according to intervention technique-half will be allocated to the bipolar coagulation group and half to the SURGIFLO group.
Patients will be assessed both pre-operatively and 6 months post-operatively by blood tests including follicle stimulating hormone (FSH), lutenizing hormone (LH), Estrogen (E2), Progesterone and anti-mullerian hormone (AMH) levels, and sonographic evaluation of ovarian volume and antral follicle count.
Patients undergoing elective laparoscopic ovarian cystectomy will be recruited after signing an informed consent, and randomly divided into 2 groups according to intervention technique-half will be allocated to the bipolar coagulation group and half to the SURGIFLO group.
Patients will be assessed both pre-operatively and 6 months post-operatively by blood tests including FSH, LH, E2, Progesterone and AMH levels, and sonographic evaluation of ovarian volume and antral follicle count.
Antral follicle count will be performed on the cyst post-surgery using light microscopy. The difference in hormone levels, especially AMH reflects the damage done during surgery to the ovarian reserve. Sonographic signs including a decrease in ovarian volume and antral follicle count also reflect the damage done during surgery to the ovarian reserve.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hemostasis with bipolar coagulation | Active Comparator | Patients undergoing laparoscopic ovarian cystectomy with bipolar coagulation hemostasis. |
|
| Hemostasis with SURGIFLO | Experimental | Patients undergoing laparoscopic ovarian cystectomy with SURGIFLO hemostasis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bipolar coagulation forceps (ETHICON inc.) | Device | Hemostasis of the base of the ovarian cyst by utilization of a bipolar coagulation device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Decline in ovarian reserve. | Decline rate of AMH levels before and 6 months after surgery. | Up to 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Sonographic decline in ovarian volume | Decline rate of ovarian volume before and 6 months after surgery. | Up to 6 months |
| Sonographic decline in ovarian antral follicle count | Decline rate of ovarian antral follicle count before and 6 months after surgery. |
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Inclusion Criteria:
Exclusion Criteria:
Female patients with operable ovarian cysts with clear indication for surgery.
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| Name | Affiliation | Role |
|---|---|---|
| Roy Lauterbach, MD | Rambam Health Care Campus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rambam health care campus | Haifa | Israel |
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| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| ID | Term |
|---|---|
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
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| SURGIFLO hemostatic matrix (ETHICON inc.) | Device | Hemostasis of the base of the ovarian cyst by utilization of a an absorbable gelatin based matrix known as SURGIFLO. |
|
| Up to 6 months |
| Changes in FSH levels | Changes in FSH levels before and 6 months after surgery. | Up to 6 months. |
| Changes in LH levels | Changes in LH levels before and 6 months after surgery. | Up to 6 months |
| Changes in Progesterone levels | Changes in Progesterone levels before and 6 months after surgery. | Up to 6 months |
| Changes in E2 levels | Changes in E2 levels before and 6 months after surgery. | Up to 6 months |
| Number of antral follicles in the cyst removed from the ovary. | Number of antral follicles in the cyst removed from the ovary as seen utilizing light microscopy. | Up to 6 months. |
| D005831 |
| Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |