Ovarian ReserveNCT01268930
Comparison of Hemostatic Matrix and Bipolar Coagulation in Surgical Treatment of Endometriomas
A study testing Bipolar electrocautery for ovarian hemostasis and hemostatic matrix (FloSeal) in people with Ovarian Reserve and Endometrioma, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
In this study, impacts of hemostatic matrix and bipolar electrocoagulation on ovarian reserve in women undergoing ovarian endometrioma excision are compared. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Ovarian Reserve, Endometrioma
- What is being tested?
- Bipolar electrocautery for ovarian hemostasis and hemostatic matrix (FloSeal)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Sep 2010to Mar 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients in reproductive ages
- Presence of ovarian endometrioma at least 4 centimeter in size
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University Medical Faculty Hospital
Ankara, 06100
About this study
In this study, impacts of hemostatic matrix and bipolar electrocoagulation on ovarian reserve in women undergoing ovarian endometrioma excision are compared.
Read the 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.
- Conditions
- Ovarian Reserve, Endometrioma
- Being tested
- Bipolar electrocautery for ovarian hemostasis, hemostatic matrix (FloSeal)
- Keywords
- ovarian reserve, endometrioma excision, hemostatic matrix, bipolar electrocoagulation, thermal injury
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bipolar electrocautery for ovarian hemostasisProcedure or surgery
after surgical excision of ovarian endometrioma with cyst wall, bipolar electrocoagulation is used to control of bleeding.
hemostatic matrix (FloSeal)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Bipolar coagulation | Active comparator | In this arm, after the complete excision of ovarian endometrioma, ovarian hemostasis is provided by bipolar electrocoagulation. Receives: Procedure: Bipolar electrocautery for ovarian hemostasis |
| Hemostatic matrix | Active comparator | In this arm, after complete excision of ovarian endometrioma, ovarian hemostasis is provided by hemostatic matrix. Receives: Procedure: hemostatic matrix (FloSeal) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within preoperative 1 week, postoperative at 1 and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2011 (estimated)
- Study startSep 2010
- Primary completionFeb 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian ReserveStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01268930
- Sponsor's protocol ID
- hemostaticmatrix
- Status last verified
- Dec 2010
- First submitted
- 3 Jan 2011
- Last updated
- 22 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Hemostatic Matrix and Bipolar Coagulation in Surgical Treatment of Endometriomas
- ClinicalTrials.gov ID
- NCT01268930
- Acronym / sponsor ID
- hemostaticmatrix
- Conditions
- Ovarian Reserve, Endometrioma
- Keywords
- ovarian reserve, endometrioma excision, hemostatic matrix, bipolar electrocoagulation, thermal injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 4 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bipolar coagulation | Active comparator | Procedure: Bipolar electrocautery for ovarian hemostasisIn this arm, after the complete excision of ovarian endometrioma, ovarian hemostasis is provided by bipolar electrocoagulation. |
| Hemostatic matrix | Active comparator | Procedure: hemostatic matrix (FloSeal)In this arm, after complete excision of ovarian endometrioma, ovarian hemostasis is provided by hemostatic matrix. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients in reproductive ages
- Presence of ovarian endometrioma at least 4 centimeter in size
Key exclusion criteria (6 listed)
- Previous ovarian surgery
- Pregnancy
- Lactation
- Diabetes Mellitus, thyroid or adrenal disorders, hyperprolactinemia
- History or suspicion of malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bipolar electrocautery for ovarian hemostasisafter surgical excision of ovarian endometrioma with cyst wall, bipolar electrocoagulation is used to control of bleeding. | Procedure or surgery | Bipolar coagulation |
| 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. | Procedure or surgery | Hemostatic matrix |
Primary outcome
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bipolar electrocautery for ovarian hemostasis and hemostatic matrix (FloSeal) in people with Ovarian Reserve and Endometrioma, run by Ankara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2011.