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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
Sponsor:
Information provided by (Responsible Party):
Taejong Song, CHA University

Brief 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.


Condition or disease Intervention/treatment Phase
Ovarian Cysts Procedure: Floseal Procedure: Bipolar coagulation Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cysts
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Floseal
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.
Procedure: Floseal
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



Primary Outcome Measures :
  1. 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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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01857466


Locations
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
Sponsors and Collaborators
CHA University
Investigators
Principal Investigator: Taejong Song, M.D CHA Gangnam Medical Center, Seoul, Republic of Korea

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Taejong Song, Professor, CHA University
ClinicalTrials.gov Identifier: NCT01857466     History of Changes
Other Study ID Numbers: KNC13-017
First Posted: May 20, 2013    Key Record Dates
Last Update Posted: June 25, 2014
Last Verified: June 2014

Additional relevant MeSH terms:
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases