Cyst Ovary
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEBipolar coagulation forceps (ETHICON inc.)
Hemostasis of the base of the ovarian cyst by utilization of a bipolar coagulation device.
DEVICESURGIFLO hemostatic matrix (ETHICON inc.)
Hemostasis of the base of the ovarian cyst by utilization of a an absorbable gelatin based matrix known as SURGIFLO.
Sponsors
Rambam Health Care Campus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 44 Years
Healthy volunteers
No
Inclusion criteria
* Female patients with benign ovarian cysts that are interested in future fertility ages 18-44.
Exclusion criteria
* Female patients with malignant ovarian cysts/masses.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decline in ovarian reserve. | Up to 6 months. | Decline rate of AMH levels before and 6 months after surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sonographic decline in ovarian antral follicle count | Up to 6 months | Decline rate of ovarian antral follicle count before and 6 months after surgery. |
| Changes in FSH levels | Up to 6 months. | Changes in FSH levels before and 6 months after surgery. |
| Changes in LH levels | Up to 6 months | Changes in LH levels before and 6 months after surgery. |
| Sonographic decline in ovarian volume | Up to 6 months | Decline rate of ovarian volume before and 6 months after surgery. |
| Changes in E2 levels | Up to 6 months | Changes in E2 levels before and 6 months after surgery. |
| Number of antral follicles in the cyst removed from the ovary. | Up to 6 months. | Number of antral follicles in the cyst removed from the ovary as seen utilizing light microscopy. |
| Changes in Progesterone levels | Up to 6 months | Changes in Progesterone levels before and 6 months after surgery. |
Countries
Israel
Outcome results
None listed