Trial record 7 of 379 for:    Ovarian Cysts: Ovarian Cysts

Ovarian Reserve After Ovarian Hemostasis by Floseal Matrix

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Taejong Song, CHA University
ClinicalTrials.gov Identifier:
NCT01857466
First received: May 16, 2013
Last updated: June 24, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Ovarian Cysts
Procedure: Floseal
Procedure: Bipolar coagulation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by CHA University:

Primary Outcome Measures:
  • Decline rate of serum AMH levels [ Time Frame: 3 months after therapy ] [ Designated as safety issue: No ]
    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.


Enrollment: 100
Study Start Date: December 2012
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by CHA University

Additional 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
Study First Received: May 16, 2013
Last Updated: June 24, 2014
Health Authority: Republic of Korea: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 19, 2014