Comparison of Hemostatic Matrix and Bipolar Coagulation in Surgical Treatment of Endometriomas
NCT ID: NCT01268930
Last Updated: 2011-06-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2010-09-30
2011-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Bipolar coagulation
In this arm, after the complete excision of ovarian endometrioma, ovarian hemostasis is provided by bipolar electrocoagulation.
Bipolar electrocautery for ovarian hemostasis
after surgical excision of ovarian endometrioma with cyst wall, bipolar electrocoagulation is used to control of bleeding.
Hemostatic matrix
In this arm, after complete excision of ovarian endometrioma, ovarian hemostasis is provided by hemostatic matrix.
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.
Interventions
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Bipolar electrocautery for ovarian hemostasis
after surgical excision of ovarian endometrioma with cyst wall, bipolar electrocoagulation is used to control of bleeding.
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.
Eligibility Criteria
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Inclusion Criteria
* Presence of ovarian endometrioma at least 4 centimeter in size
Exclusion Criteria
* 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
18 Years
40 Years
FEMALE
No
Sponsors
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Ankara University
OTHER
Responsible Party
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Ankara University
Locations
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Ankara University Medical Faculty Hospital
Ankara, , Turkey (Türkiye)
Countries
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Other Identifiers
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hemostaticmatrix
Identifier Type: -
Identifier Source: org_study_id
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