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

Cyst Ovary Clinical Trial

Official title:

The Affect of Hemostasis With Bipolar Coagulation Versus SURGIFLO Placement on Ovarian Reserve and Future Fertility

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03109964
• Other study ID #: 0232-17-RMB
• Status: Completed
• Phase: N/A
• Start date: November 20, 2018
• Est. completion date: August 1, 2022

Study information

• Verified date: October 2022
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: August 1, 2022
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cyst Ovary
• Ovarian Cysts

Intervention

Device:
• Bipolar coagulation forceps (ETHICON inc.)
Hemostasis of the base of the ovarian cyst by utilization of a bipolar coagulation device.
• SURGIFLO hemostatic matrix (ETHICON inc.)
Hemostasis of the base of the ovarian cyst by utilization of a an absorbable gelatin based matrix known as SURGIFLO.

Locations

Country	Name	City	State
Israel	Rambam health care campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decline in ovarian reserve.	Decline rate of AMH levels before and 6 months after surgery.	Up to 6 months.
Secondary	Sonographic decline in ovarian volume	Decline rate of ovarian volume before and 6 months after surgery.	Up to 6 months
Secondary	Sonographic decline in ovarian antral follicle count	Decline rate of ovarian antral follicle count before and 6 months after surgery.	Up to 6 months
Secondary	Changes in FSH levels	Changes in FSH levels before and 6 months after surgery.	Up to 6 months.
Secondary	Changes in LH levels	Changes in LH levels before and 6 months after surgery.	Up to 6 months
Secondary	Changes in Progesterone levels	Changes in Progesterone levels before and 6 months after surgery.	Up to 6 months
Secondary	Changes in E2 levels	Changes in E2 levels before and 6 months after surgery.	Up to 6 months
Secondary	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.