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Comparison of Hemostatic Matrix and Bipolar Coagulation in Surgical Treatment of Endometriomas

Primary Purpose

Ovarian Reserve, Endometrioma

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Bipolar electrocautery for ovarian hemostasis
hemostatic matrix (FloSeal)
Sponsored by
Ankara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Reserve focused on measuring ovarian reserve, endometrioma excision, hemostatic matrix, bipolar electrocoagulation, thermal injury

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients in reproductive ages
  • Presence of ovarian endometrioma at least 4 centimeter in size

Exclusion Criteria:

  • Previous ovarian surgery
  • Pregnancy
  • Lactation
  • Diabetes Mellitus, thyroid or adrenal disorders, hyperprolactinemia
  • History or suspicion of malignancy
  • Use of oral contraceptive drug, GnRH agonist or antagonist, danazol and other drug relation with ovarian function in last 6 months

Sites / Locations

  • Ankara University Medical Faculty Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Bipolar coagulation

Hemostatic matrix

Arm Description

In this arm, after the complete excision of ovarian endometrioma, ovarian hemostasis is provided by bipolar electrocoagulation.

In this arm, after complete excision of ovarian endometrioma, ovarian hemostasis is provided by hemostatic matrix.

Outcomes

Primary Outcome Measures

preoperative and at 1 and 3 months postoperatively ovarian reserve differences will be measured by serum anti mullerian hormone between two groups (hemostatic matrix and bipolar coagulation groups)
Group 1: after excision of ovarian endometrioma with its wall hemostatic matrix is used to provide hemostasis in the bed of endometrioma. Group 2: after excision of ovarian endometrioma with its wall bipolar elektrocoagulation is used to provide hemostasis in the bed of endometrioma. At the end of study antimullerian hormone values as an indicator of ovarian reserve will be compared.

Secondary Outcome Measures

Full Information

First Posted
January 3, 2011
Last Updated
June 21, 2011
Sponsor
Ankara University
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1. Study Identification

Unique Protocol Identification Number
NCT01268930
Brief Title
Comparison of Hemostatic Matrix and Bipolar Coagulation in Surgical Treatment of Endometriomas
Study Type
Interventional

2. Study Status

Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ankara University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
In this study, impacts of hemostatic matrix and bipolar electrocoagulation on ovarian reserve in women undergoing ovarian endometrioma excision are compared.
Detailed Description
Endometriosis is defined as the existence of endometrial tissue outside of the uterine cavity. Ovaries are the most common effected sites and the disease causes endometriotic cysts in the ovaries. The treatment of endometriomas is still highly controversial. It is well known that the ovarian reserve is compromised as a result of endometriomas. Even though a variety of medical agents can be used to treat endometriomas, when endometriomas cause pelvic pain or infertility especially when they are > 4cm in size, surgical treatment can be offered. Even though there is no standard surgical treatment removal of cyst wall is usually the preferred method. Aspiration of cyst fluid and coagulation of the cyst wall have been practiced, however are associated with more recurrences. Nevertheless, the impact of surgical treatment on ovarian reserve has not been clarified. There are mainly two types of ovarian injury during surgical removal of endometriomas. First, there is risk that the healthy ovarian tissue can be removed along with the cyst wall. Second, there is risk of of thermal injury that occurs after cyst removal during hemostasis by electrocoagulation. By this context, investigating an alternative method to electrocautery which causes less thermal injury to ovary would open a new strategy in the treatment of infertile patients with endometrioma. A new method "hemostatic matrix" has been developed to provide hemostasis. Endometriomas can be treated without thermal injury to healthy ovarian tissue using this method compared to bipolar coagulation. In the literature, there is no controlled randomized study compared hemostatic matrix and bipolar coagulation for impact on ovarian reserve after treatment ovarian endometriomas. There are two main principles when treating endometriomas. First, recurrence should not occur, and the second is minimal ovarian injury. On the backgrounds of this philosophy, it can be hypothesized that hemostatic matrix can cause less damage to ovarian tissue compared to classical bipolar coagulation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Reserve, Endometrioma
Keywords
ovarian reserve, endometrioma excision, hemostatic matrix, bipolar electrocoagulation, thermal injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bipolar coagulation
Arm Type
Active Comparator
Arm Description
In this arm, after the complete excision of ovarian endometrioma, ovarian hemostasis is provided by bipolar electrocoagulation.
Arm Title
Hemostatic matrix
Arm Type
Active Comparator
Arm Description
In this arm, after complete excision of ovarian endometrioma, ovarian hemostasis is provided by hemostatic matrix.
Intervention Type
Procedure
Intervention Name(s)
Bipolar electrocautery for ovarian hemostasis
Intervention Description
after surgical excision of ovarian endometrioma with cyst wall, bipolar electrocoagulation is used to control of bleeding.
Intervention Type
Procedure
Intervention Name(s)
hemostatic matrix (FloSeal)
Intervention Description
after surgical excision of ovarian endometrioma with cyst wall, hemostatic matrix is administered to the bed of cyst for 2-3 minutes to control of bleeding. Then, area is rinsed and hemostasis is checked.
Primary Outcome Measure Information:
Title
preoperative and at 1 and 3 months postoperatively ovarian reserve differences will be measured by serum anti mullerian hormone between two groups (hemostatic matrix and bipolar coagulation groups)
Description
Group 1: after excision of ovarian endometrioma with its wall hemostatic matrix is used to provide hemostasis in the bed of endometrioma. Group 2: after excision of ovarian endometrioma with its wall bipolar elektrocoagulation is used to provide hemostasis in the bed of endometrioma. At the end of study antimullerian hormone values as an indicator of ovarian reserve will be compared.
Time Frame
within preoperative 1 week, postoperative at 1 and 3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients in reproductive ages Presence of ovarian endometrioma at least 4 centimeter in size Exclusion Criteria: Previous ovarian surgery Pregnancy Lactation Diabetes Mellitus, thyroid or adrenal disorders, hyperprolactinemia History or suspicion of malignancy Use of oral contraceptive drug, GnRH agonist or antagonist, danazol and other drug relation with ovarian function in last 6 months
Facility Information:
Facility Name
Ankara University Medical Faculty Hospital
City
Ankara
ZIP/Postal Code
06100
Country
Turkey

12. IPD Sharing Statement

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Comparison of Hemostatic Matrix and Bipolar Coagulation in Surgical Treatment of Endometriomas

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