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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Cyst Ovary

Intervention / Treatment
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* Device: Bipolar coagulation forceps (ETHICON inc.)
* Device: SURGIFLO hemostatic matrix (ETHICON inc.)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hemostasis with bipolar coagulation<br>Patients undergoing laparoscopic ovarian cystectomy with bipolar coagulation hemostasis. | Device: Bipolar coagulation forceps (ETHICON inc.)<br>* Hemostasis of the base of the ovarian cyst by utilization of a bipolar coagulation device.<br>|
| Experimental: Hemostasis with SURGIFLO<br>Patients undergoing laparoscopic ovarian cystectomy with SURGIFLO hemostasis. | Device: SURGIFLO hemostatic matrix (ETHICON inc.)<br>* Hemostasis of the base of the ovarian cyst by utilization of a an absorbable gelatin based matrix known as SURGIFLO.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decline in ovarian reserve. | Decline rate of AMH levels before and 6 months after surgery. | Up to 6 months. | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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. |