Trial record 7 of 355 for:    Ovarian Cysts: Ovarian Cysts

Ovarian Reserve After Ovarian Hemostasis by Floseal Matrix

This study is currently recruiting participants.
Verified October 2013 by CHA University
Sponsor:
Information provided by (Responsible Party):
Taejong Song, CHA University
ClinicalTrials.gov Identifier:
NCT01857466
First received: May 16, 2013
Last updated: October 17, 2013
Last verified: October 2013
  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.


Estimated Enrollment: 100
Study Start Date: December 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01857466

Contacts
Contact: Taejong Song, M.D. +82-10-4035-8405 taejong.song@gmail.com

Locations
Korea, Republic of
National Health Insurance Service Ilsan Hospital Recruiting
Goyang, Korea, Republic of
Contact: San-Hui Lee, M.D.    +81-10-9948-4459    sanaram@naver.com   
Principal Investigator: San-Hui Lee, M.D.         
CHA Gangnam Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Taejong Song, M.D.    +81-10-4035-8405    taejong.song@gmail.com   
Principal Investigator: Taejong Song, M.D.         
Kangbuk Samsung Hospital, Sungkyunkwan University Recruiting
Seoul, Korea, Republic of
Contact: Woo Young Kim, M.D.    +81-10-5343-3481    obgykim@gmail.com   
Principal Investigator: Woo Young Kim, M.D.         
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

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: October 17, 2013
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 April 15, 2014