Ovarian Reserve After Ovarian Hemostasis by Floseal Matrix

Ovarian Cysts Clinical Trial

Official title:

Additional Benefit of Hemostatic Sealant in Preserving Ovarian Reserve During Laparoscopic Ovarian Cystectomy: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01857466
• Other study ID #: KNC13-017
• Status: Completed
• Phase: Phase 3
• First received: May 16, 2013
• Last updated: June 24, 2014
• Start date: December 2012
• Est. completion date: October 2013

Study information

• Verified date: June 2014
• Source: CHA University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Republic of Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Laparoscopy has become the gold standard for the surgical treatment of benign ovarian cysts and is usually performed by stripping the ovarian cyst wall, followed by bleeding control of the ovarian wound ground using bipolar coagulation. However, the hemostasis with bipolar coagulation could result in the damage of ovarian reserve and decrease the response of the ovaries to hormonal stimulation for assisted reproductive technologies. The possible mechanism may contribute to thermal destruction of ovarian follicles by excessive use of bipolar coagulation for hemostasis purposes.

To avoid additional ovarian tissue damage by conventional bipolar coagulation being potentially important ovarian reproductive function, hemostasis using various topical hemostatic agents has introduced to control post-cystectomy ovarian wound bleeding. Among them, FloSeal (Baxter Healthcare Corporation, Deerfield, IL, USA) is a hemostatic matrix sealant composed of a gelatin-based matrix and thrombin solution. On coming into contact with blood after application at a bleeding site, the gelatin particles swell and tamponade bleeding. The bulk of the gelatin matrix-thrombin composite has the effect of slowing blood flow and providing exposure to a high thrombin concentration, thus hastening clot formation. Therefore, it may more suitable for use in post-cystectomy ovarian wound bleeding, where there is superficially pervasive focus of bleeding.

Ovarian reserve is defined as the functional potential of the ovary, which reflects the number and quality of antral follicles left in the ovary, and is correlated with the response to ovarian stimulation using exogenous gonadotropin. Serum anti-Müllerian hormone (AMH) has been accepted as the most reliable and easily measurable marker for postoperative assessment of ovarian reserve.

The investigators conducted a multicenter, large-scale, randomized controlled trial to investigate whether hemostasis by Floseal was superior to that by bipolar coagulation in preserving ovarian reserve by assessing serial AMH levels in patients undergoing laparoscopic ovarian cystectomy for benign ovarian cysts.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• age between 18 and 45 years

• maximum diameter of the cyst between 3 and 10 cm

• regular menstrual bleeding (defined as cycle length less than 21 or more than 45 days)

• appropriate medical status for laparoscopic surgery (American Society of Anesthesiologists Physical Status classification 1 or 2).

Exclusion Criteria:

• any suspicious finding of malignant ovarian diseases

• postmenopausal status

• baseline serum AMH < 0.50 ng/mL

• pregnancy

• lactation

• any other endocrine diseases (such as thyroid dysfunction, hyperprolactinemia, or Cushing's syndrome)

• use of hormonal treatments in the 3 months before enrollment

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ovarian Cysts

Intervention

Procedure:
• Floseal

• Bipolar coagulation

Locations

Country	Name	City	State
Korea, Republic of	National Health Insurance Service Ilsan Hospital	Goyang
Korea, Republic of	CHA Gangnam Medical Center	Seoul
Korea, Republic of	Kangbuk Samsung Hospital, Sungkyunkwan University	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
CHA University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decline rate of serum AMH levels	The primary outcome of the study was the impact on ovarian reserve determined by serum AMH levels after the applications of two hemostatic techniques for ovarian wound bleeding.	3 months after therapy	No