Comparison of Hemostatic Matrix and Bipolar Coagulation in Surgical Treatment of Endometriomas
1 other identifier
interventional
30
1 country
1
Brief Summary
In this study, impacts of hemostatic matrix and bipolar electrocoagulation on ovarian reserve in women undergoing ovarian endometrioma excision are compared.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2010
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 3, 2011
CompletedFirst Posted
Study publicly available on registry
January 4, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedJune 22, 2011
December 1, 2010
5 months
January 3, 2011
June 21, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Bipolar coagulation
ACTIVE COMPARATORIn this arm, after the complete excision of ovarian endometrioma, ovarian hemostasis is provided by bipolar electrocoagulation.
Hemostatic matrix
ACTIVE COMPARATORIn this arm, after complete excision of ovarian endometrioma, ovarian hemostasis is provided by hemostatic matrix.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Patients in reproductive ages
- Presence of ovarian endometrioma at least 4 centimeter in size
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ankara University Medical Faculty Hospital
Ankara, 06100, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 3, 2011
First Posted
January 4, 2011
Study Start
September 1, 2010
Primary Completion
February 1, 2011
Study Completion
March 1, 2011
Last Updated
June 22, 2011
Record last verified: 2010-12