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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01268930
• Date of registration: 03/01/2011
• Prospective Registration: No
• Primary sponsor: Ankara University
• Public title: Comparison of Hemostatic Matrix and Bipolar Coagulation in Surgical Treatment of Endometriomas
• Date of first enrolment: September 2010
• Target sample size: 30
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01268930
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Turkey

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 40 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Ovarian Reserve

Endometrioma

Intervention(s)

Procedure: Bipolar electrocautery for ovarian hemostasis

Procedure: hemostatic matrix (FloSeal)

Primary Outcome(s)

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]

Secondary ID(s)

hemostaticmatrix

Source(s) of Monetary Support

Please refer to primary and secondary sponsors