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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
  Purpose

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


Condition Intervention
Ovarian Reserve
Endometrioma
Procedure: Bipolar electrocautery for ovarian hemostasis
Procedure: hemostatic matrix (FloSeal)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Further study details as provided by Ankara University:

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) [ 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.



Enrollment: 30
Study Start Date: September 2010
Study Completion Date: March 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01268930

Locations
Turkey
Ankara University Medical Faculty Hospital
Ankara, Turkey, 06100
Sponsors and Collaborators
Ankara University
  More Information

No publications provided

Responsible Party: Salih Taskin, Ankara University
ClinicalTrials.gov Identifier: NCT01268930     History of Changes
Other Study ID Numbers: hemostaticmatrix
Study First Received: January 3, 2011
Last Updated: June 21, 2011
Health Authority: Turkey: Ethics Committee

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

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female
Hemostatics
Coagulants
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014