The Affect of Hemostasis Technique During Laparoscopic Ovarian Cystectomy on Future Fertility

Rambam Health Care Campus

Status: Completed

Conditions: Cyst Ovary

Treatments: Device: SURGIFLO hemostatic matrix (ETHICON inc.); Device: Bipolar coagulation forceps (ETHICON inc.)

Study type: Interventional

Funder types: Other

Identifiers

NCT03109964

0232-17-RMB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 127 patients

Sex: Female

Ages: 18 to 44 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

127 participants in 2 patient groups

Hemostasis with bipolar coagulation

Active Comparator group

Description:

Patients undergoing laparoscopic ovarian cystectomy with bipolar coagulation hemostasis.

Treatment:

Device: Bipolar coagulation forceps (ETHICON inc.)

Hemostasis with SURGIFLO

Experimental group

Description:

Patients undergoing laparoscopic ovarian cystectomy with SURGIFLO hemostasis.

Treatment:

Device: SURGIFLO hemostatic matrix (ETHICON inc.)