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

This study has been completed.
Sponsor:
Information provided by:
Ankara University
ClinicalTrials.gov Identifier:
NCT01268930
First received: January 3, 2011
Last updated: June 21, 2011
Last verified: December 2010

January 3, 2011
June 21, 2011
September 2010
February 2011   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]

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.

Defined of preoperative and at 3 months postoperatively ovarian reserve differences which 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 ] [ Designated as safety issue: Yes ]

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.

Complete list of historical versions of study NCT01268930 on ClinicalTrials.gov Archive Site
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Comparison of Hemostatic Matrix and Bipolar Coagulation in Surgical Treatment of Endometriomas
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In this study, impacts of hemostatic matrix and bipolar electrocoagulation on ovarian reserve in women undergoing ovarian endometrioma excision are compared.

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.

Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Ovarian Reserve
  • Endometrioma
  • Procedure: Bipolar electrocautery for ovarian hemostasis
    after surgical excision of ovarian endometrioma with cyst wall, bipolar electrocoagulation is used to control of bleeding.
  • 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.
  • Active Comparator: Bipolar coagulation
    In this arm, after the complete excision of ovarian endometrioma, ovarian hemostasis is provided by bipolar electrocoagulation.
    Intervention: Procedure: Bipolar electrocautery for ovarian hemostasis
  • Active Comparator: Hemostatic matrix
    In this arm, after complete excision of ovarian endometrioma, ovarian hemostasis is provided by hemostatic matrix.
    Intervention: Procedure: hemostatic matrix (FloSeal)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
March 2011
February 2011   (final data collection date for primary outcome measure)

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
Female
18 Years to 40 Years
No
Contact information is only displayed when the study is recruiting subjects
Turkey
 
NCT01268930
hemostaticmatrix
Yes
Salih Taskin, Ankara University
Ankara University
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Ankara University
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP