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Ovarian Reserve After Ovarian Hemostasis by Floseal Matrix

Primary Purpose

Ovarian Cysts

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Floseal
Bipolar coagulation
Sponsored by
CHA University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cysts

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • National Health Insurance Service Ilsan Hospital
  • CHA Gangnam Medical Center
  • Kangbuk Samsung Hospital, Sungkyunkwan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Floseal

Bipolar coagulation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 16, 2013
Last Updated
June 24, 2014
Sponsor
CHA University
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1. Study Identification

Unique Protocol Identification Number
NCT01857466
Brief Title
Ovarian Reserve After Ovarian Hemostasis by Floseal Matrix
Official Title
Additional Benefit of Hemostatic Sealant in Preserving Ovarian Reserve During Laparoscopic Ovarian Cystectomy: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
CHA University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cysts

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Floseal
Arm Type
Experimental
Arm Description
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.
Arm Title
Bipolar coagulation
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Floseal
Intervention Type
Procedure
Intervention Name(s)
Bipolar coagulation
Primary Outcome Measure Information:
Title
Decline rate of serum AMH levels
Description
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.
Time Frame
3 months after therapy

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Taejong Song, M.D
Organizational Affiliation
CHA Gangnam Medical Center, Seoul, Republic of Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Health Insurance Service Ilsan Hospital
City
Goyang
Country
Korea, Republic of
Facility Name
CHA Gangnam Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Kangbuk Samsung Hospital, Sungkyunkwan University
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
24903197
Citation
Song T, Lee SH, Kim WY. Additional benefit of hemostatic sealant in preservation of ovarian reserve during laparoscopic ovarian cystectomy: a multi-center, randomized controlled trial. Hum Reprod. 2014 Aug;29(8):1659-65. doi: 10.1093/humrep/deu125. Epub 2014 Jun 4.
Results Reference
derived

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Ovarian Reserve After Ovarian Hemostasis by Floseal Matrix

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