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

Endometrioma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01268930
• Other study ID #: hemostaticmatrix
• Status: Completed
• Phase: N/A
• First received: January 3, 2011
• Last updated: June 21, 2011
• Start date: September 2010
• Est. completion date: March 2011

Study information

• Verified date: December 2010
• Source: Ankara University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Endometrioma
• Endometriosis
• Ovarian Reserve

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Turkey	Ankara University Medical Faculty Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	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.	within preoperative 1 week, postoperative at 1 and 3 months	Yes