Comparison of Hemostatic Matrix and Bipolar Coagulation in Surgical Treatment of Endometriomas
Condition: Ovarian Reserve; Endometrioma
MeSH terms: Endometriosis
Study type: Interventional

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.
    

Intervention name(s): Bipolar electrocautery for ovarian hemostasis; hemostatic matrix (FloSeal)
Intervention type(s): Procedure; Procedure
Intervention description(s): after surgical excision of ovarian endometrioma with cyst wall, bipolar electrocoagulation is used to control of bleeding.; 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.
Intervention MeSH terms: Hemostatics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ovarian reserve; endometrioma excision; hemostatic matrix; bipolar electrocoagulation; thermal injury