Ovarian Reserve After Ovarian Hemostasis by Floseal Matrix
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|ClinicalTrials.gov Identifier: NCT01857466|
Recruitment Status : Completed
First Posted : May 20, 2013
Last Update Posted : June 25, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cysts||Procedure: Floseal Procedure: Bipolar coagulation||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Additional Benefit of Hemostatic Sealant in Preserving Ovarian Reserve During Laparoscopic Ovarian Cystectomy: a Randomized Controlled Trial|
|Study Start Date :||December 2012|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||October 2013|
In the Floseal group, the sites of bleeding were covered with Floseal under direct vision with a laparoscopic applicator and ovarian cortex was closed on itself and waited for 2 minutes for Floseal to act. Then, subsequently bleeding sites were reexamined with irrigation.
Active Comparator: Bipolar coagulation
In the bipolar group, hemostasis of the ovarian parenchyma was achieved with selective minimal (20-30 watt current) bipolar coagulation without excessive coagulation of surgical defect to avoid damaging the ovary.
|Procedure: Bipolar coagulation|
- Decline rate of serum AMH levels [ Time Frame: 3 months after therapy ]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.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01857466
|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, Korea, Republic of|
|Principal Investigator:||Taejong Song, M.D||CHA Gangnam Medical Center, Seoul, Republic of Korea|