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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01268930
Recruitment Status : Completed
First Posted : January 4, 2011
Last Update Posted : June 22, 2011
Information provided by:
Ankara University

Brief Summary:
In this study, impacts of hemostatic matrix and bipolar electrocoagulation on ovarian reserve in women undergoing ovarian endometrioma excision are compared.

Condition or disease Intervention/treatment Phase
Ovarian Reserve Endometrioma Procedure: Bipolar electrocautery for ovarian hemostasis Procedure: hemostatic matrix (FloSeal) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : September 2010
Actual Primary Completion Date : February 2011
Actual Study Completion Date : March 2011

Arm Intervention/treatment
Active Comparator: Bipolar coagulation
In this arm, after the complete excision of ovarian endometrioma, ovarian hemostasis is provided by bipolar electrocoagulation.
Procedure: Bipolar electrocautery for ovarian hemostasis
after surgical excision of ovarian endometrioma with cyst wall, bipolar electrocoagulation is used to control of bleeding.

Active Comparator: Hemostatic matrix
In this arm, after complete excision of ovarian endometrioma, ovarian hemostasis is provided by hemostatic matrix.
Procedure: hemostatic matrix (FloSeal)
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 Measures :
  1. 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) [ Time Frame: within preoperative 1 week, postoperative at 1 and 3 months ]

    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.

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT01268930

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Ankara University Medical Faculty Hospital
Ankara, Turkey, 06100
Sponsors and Collaborators
Ankara University

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Responsible Party: Salih Taskin, Ankara University Identifier: NCT01268930     History of Changes
Other Study ID Numbers: hemostaticmatrix
First Posted: January 4, 2011    Key Record Dates
Last Update Posted: June 22, 2011
Last Verified: December 2010

Keywords provided by Ankara University:
ovarian reserve
endometrioma excision
hemostatic matrix
bipolar electrocoagulation
thermal injury

Additional relevant MeSH terms:
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Genital Diseases, Female