EndometriomaRupturedOMANCT05348070
Comparison of Operated Ruptured and Non-ruptured Endometriomas
An observational study of Endometrioma and Ruptured Endometrioma, run by EZH EAH at 1 site in Turkey (Türkiye).
Trial summary
Ruptured endometrioma cases were compared with unruptured endometrioma cases. Read more about this study
- Who is it for?
- Ages 16 to 48 years, women only
- Conditions the study is for
- Endometrioma, Ruptured Endometrioma, Endometriosis Ovary
- What is being tested?
- Laparoscopy/Laparotomy
- Type of treatment
- Surgery or procedure
- How many people
- 181 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2014to 20 Jun 2021
- Phase
- Observational
- 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 16 to 48 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Patients who were operated on in Republic of Turkey Ministry of Health, Health Science University Etlik Zübeyde Hanım Gynecology Training and Research Hospital Infertility Clinic, whose histopathological diagnosis was confirmed as endometrioma. All patients were women of reproductive age with a pelvic mass.
Who may be able to join
- All patients who were operated on in Republic of Turkey Ministry of Health, Health Science University Etlik Zübeyde Hanım Gynecology Training and Research Hospital Infertility Clinic, whose histopathological diagnosis was confirmed as endometrioma, and who did not meet the exclusion criteria, were included in the study.
Who cannot join
- Patients who were operated with a prediagnosis of endometrioma and whose pathological diagnosis was different
- Patients with smoking, alcohol, substance abuse
- Patients receiving pelvic radiotherapy/chemotherapy
- Patients with suspected or confirmed malignancies
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Republic of Turkey Ministry of Health, Health Science University Etlik Zübeyde Hanım Gynecology Training and Research Hospital Infertility Clinic
Ankara, Keçiören, 06050
About this study
Official title: Comparison of Inflammatory Parameters in Operated Ruptured and Non-ruptured Endometriomas
Ruptured endometrioma cases were compared with unruptured endometrioma cases.
Read the detailed description
This study aims to compare the findings in patients who had surgery for ruptured endometrioma with the patients who had an unruptured endometrioma.
This study was conducted at Republic of Turkey Ministry of Health, Health Science University Etlik Zübeyde Hanım Gynecology Training and Research Hospital Infertility Clinic and all patients who were operated for endometrioma and had a histopathology report confirming the presence of endometrioma between January 2014 and December 2020 were included.
In this study, demographic characteristics, intraoperative findings, laboratory values and follow-up recommendations of two groups compared. The patients' age, presence of sexual activity and/or infertility, gravidity, parity, abortion, history of ectopic pregnancy, accompanying systemic disease, previous operations, drug use, and symptoms were recorded. Preoperative and postoperative complete blood count, Cancer antigen 125 (CA 125), Cancer antigen 19-9 (CA19-9), Cancer antigen 15-3 (CA 15-3), Carcinoembryonic antigen (CEA), alpha fetoprotein (AFP), anti mullerian hormone (AMH), fibrinogen, C-reactive protein (CRP) values of the patients were obtained. Patient files, operation notes and laboratory values of the electronic recording system database and the two groups were compared.
- Conditions
- Endometrioma, Ruptured Endometrioma, Endometriosis Ovary
- Being tested
- Laparoscopy/Laparotomy
- Keywords
- endometrioma, rupture, endometriosis
- Medical subject headings
- Endometriosis, Rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopy/LaparotomyProcedure or surgery
All patients included in the study were operated patients.
| Study group | Role | What they receive |
|---|---|---|
| Operated Non-Ruptured Endometrioma Group | It consists of patients who were found to have endometrioma in their clinical follow-ups and decided to operate as a result of the evaluations. The patients were operated under elective conditions. Receives: Procedure: Laparoscopy/Laparotomy | |
| Operated Ruptured Endometrioma Group | Rupture of endometrioma, which is a rare gynecological emergency. This group consists of endometrioma patients requiring urgent/subacute operation such as acute abdominal pain, hemodynamic instability, intra-abdominal bleeding. The patients were operated after completing the necessary preparations Receives: Procedure: Laparoscopy/Laparotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-interventional Comparison of inflammatory parameters
Neutrophil/Lymphocyte ratio (NLR), Platelet/Lymphocyte ratio (PLR), Monocyte/Lymphocyte ratio (MLR) were compared between two groups in the preoperative period
Measured: Blood samples were taken from the patients before the surgery
Comparison of inflammatory parameters after surgery
Neutrophil/Lymphocyte ratio (NLR), Platelet/Lymphocyte ratio (PLR), Monocyte/Lymphocyte ratio (MLR) were compared between two groups in the postoperative period
Measured: Blood samples were taken from the patients in the first postoperative day.
Pre-interventional Comparison of tumor markers
Cancer antigens; CA125, CA19-9 and CA 15-3 were compared between two groups in the preoperative period
Measured: Blood samples were taken from the patients before the surgery
Comparison of tumor markers after surgery
Cancer antigens; CA125, CA19-9 and CA 15-3 were compared between two groups in the postoperative period
Measured: Blood samples were taken from the patients after the surgery up to 24 weeks
Secondary outcomes (2)
Sexual activity
The existence of sexual activity in each study group was questioned.
Measured: Before surgery
Infertility
The existence of infertility in each study group was questioned.
Measured: Before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start1 Jan 2014
- Primary completion31 Dec 2020
- Study completion20 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for EndometriomaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- EZH EAH
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MD. Ayşe Gülen Erturun, EZH EAH
- Investigators
- Berna Dilbaz, Prof., Study director, Etlik Zübeyde Hanım Gynecology Training and Research Hospital Infertility Clinic's Chief
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05348070
- Sponsor's protocol ID
- 2021/76
- Acronym
- RupturedOMA
- Status last verified
- Apr 2022
- First submitted
- 25 Jan 2022
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dai X, Jin C, Hu Y, Zhang Q, Yan X, Zhu F, Lin F. High CA-125 and CA19-9 levels in spontaneous ruptured ovarian endometriomas. Clin Chim Acta. 2015 Oct 23;450:362-5. doi: 10.1016/j.cca.2015.09.019. Epub 2015 Sep 25.
PubMed 26403090Huang YH, Liou JD, Hsieh CL, Shiau CS, Lo LM, Chang MY. Long-term follow-up of patients surgically treated for ruptured ovarian endometriotic cysts. Taiwan J Obstet Gynecol. 2011 Sep;50(3):306-11. doi: 10.1016/j.tjog.2010.05.002.
PubMed 22030044Tanaka K, Kobayashi Y, Dozono K, Shibuya H, Nishigaya Y, Momomura M, Matsumoto H, Iwashita M. Elevation of plasma D-dimer levels associated with rupture of ovarian endometriotic cysts. Taiwan J Obstet Gynecol. 2015 Jun;54(3):294-6. doi: 10.1016/j.tjog.2014.09.010.
PubMed 26166344
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Inflammatory Parameters in Operated Ruptured and Non-ruptured Endometriomas
- ClinicalTrials.gov ID
- NCT05348070
- Acronym / sponsor ID
- RupturedOMA / 2021/76
- Conditions
- Endometrioma, Ruptured Endometrioma, Endometriosis Ovary
- Keywords
- endometrioma, rupture, endometriosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- EZH EAHUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 20 Jun 2021 (actual)
- First posted
- 27 Apr 2022 (actual)
- 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.
Ruptured endometrioma cases were compared with unruptured endometrioma cases.
Detailed description
This study aims to compare the findings in patients who had surgery for ruptured endometrioma with the patients who had an unruptured endometrioma.
This study was conducted at Republic of Turkey Ministry of Health, Health Science University Etlik Zübeyde Hanım Gynecology Training and Research Hospital Infertility Clinic and all patients who were operated for endometrioma and had a histopathology report confirming the presence of endometrioma between January 2014 and December 2020 were included.
In this study, demographic characteristics, intraoperative findings, laboratory values and follow-up recommendations of two groups compared. The patients' age, presence of sexual activity and/or infertility, gravidity, parity, abortion, history of ectopic pregnancy, accompanying systemic disease, previous operations, drug use, and symptoms were recorded. Preoperative and postoperative complete blood count, Cancer antigen 125 (CA 125), Cancer antigen 19-9 (CA19-9), Cancer antigen 15-3 (CA 15-3), Carcinoembryonic antigen (CEA), alpha fetoprotein (AFP), anti mullerian hormone (AMH), fibrinogen, C-reactive protein (CRP) values of the patients were obtained. Patient files, operation notes and laboratory values of the electronic recording system database and the two groups were compared.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Operated Non-Ruptured Endometrioma Group | – | Procedure: Laparoscopy/LaparotomyIt consists of patients who were found to have endometrioma in their clinical follow-ups and decided to operate as a result of the evaluations. The patients were operated under elective conditions. |
| Operated Ruptured Endometrioma Group | – | Procedure: Laparoscopy/LaparotomyRupture of endometrioma, which is a rare gynecological emergency. This group consists of endometrioma patients requiring urgent/subacute operation such as acute abdominal pain, hemodynamic instability, intra-abdominal bleeding. The patients were operated after completing the necessary preparations |
Who may qualify
- Ages
- 16 to 48 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients who were operated on in Republic of Turkey Ministry of Health, Health Science University Etlik Zübeyde Hanım Gynecology Training and Research Hospital Infertility Clinic, whose histopathological diagnosis was confirmed as endometrioma. All patients were women of reproductive age with a pelvic mass.
Key inclusion criteria (1 listed)
- All patients who were operated on in Republic of Turkey Ministry of Health, Health Science University Etlik Zübeyde Hanım Gynecology Training and Research Hospital Infertility Clinic, whose histopathological diagnosis was confirmed as endometrioma, and who did not meet the exclusion criteria, were included in the study.
Key exclusion criteria (4 listed)
- Patients who were operated with a prediagnosis of endometrioma and whose pathological diagnosis was different
- Patients with smoking, alcohol, substance abuse
- Patients receiving pelvic radiotherapy/chemotherapy
- Patients with suspected or confirmed malignancies
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 |
|---|---|---|
| Laparoscopy/LaparotomyAll patients included in the study were operated patients. | Procedure or surgery | Operated Non-Ruptured Endometrioma Group, Operated Ruptured Endometrioma Group |
Primary outcome
Pre-interventional Comparison of inflammatory parameters
Time frame: Blood samples were taken from the patients before the surgery
Neutrophil/Lymphocyte ratio (NLR), Platelet/Lymphocyte ratio (PLR), Monocyte/Lymphocyte ratio (MLR) were compared between two groups in the preoperative period
Comparison of inflammatory parameters after surgery
Time frame: Blood samples were taken from the patients in the first postoperative day.
Neutrophil/Lymphocyte ratio (NLR), Platelet/Lymphocyte ratio (PLR), Monocyte/Lymphocyte ratio (MLR) were compared between two groups in the postoperative period
Pre-interventional Comparison of tumor markers
Time frame: Blood samples were taken from the patients before the surgery
Cancer antigens; CA125, CA19-9 and CA 15-3 were compared between two groups in the preoperative period
Comparison of tumor markers after surgery
Time frame: Blood samples were taken from the patients after the surgery up to 24 weeks
Cancer antigens; CA125, CA19-9 and CA 15-3 were compared between two groups in the postoperative period
2 secondary outcomes
Sexual activity
Time frame: Before surgery
Infertility
Time frame: Before surgery
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 27 Apr 2022.
- Background: PubMed 26403090Dai X, Jin C, Hu Y, Zhang Q, Yan X, Zhu F, Lin F. High CA-125 and CA19-9 levels in spontaneous ruptured ovarian endometriomas. Clin Chim Acta. 2015 Oct 23;450:362-5. doi: 10.1016/j.cca.2015.09.019. Epub 2015 Sep 25.
- Background: PubMed 22030044Huang YH, Liou JD, Hsieh CL, Shiau CS, Lo LM, Chang MY. Long-term follow-up of patients surgically treated for ruptured ovarian endometriotic cysts. Taiwan J Obstet Gynecol. 2011 Sep;50(3):306-11. doi: 10.1016/j.tjog.2010.05.002.
- Results publication: PubMed 26166344Tanaka K, Kobayashi Y, Dozono K, Shibuya H, Nishigaya Y, Momomura M, Matsumoto H, Iwashita M. Elevation of plasma D-dimer levels associated with rupture of ovarian endometriotic cysts. Taiwan J Obstet Gynecol. 2015 Jun;54(3):294-6. doi: 10.1016/j.tjog.2014.09.010.
- Individual participant dataSharing planned: No
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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.
Berna Dilbaz, Prof. study director
Etlik Zübeyde Hanım Gynecology Training and Research Hospital Infertility Clinic's Chief
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrioma and Ruptured Endometrioma, run by EZH EAH 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 1 inclusion and 4 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 27 Apr 2022. 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?
Pre-interventional Comparison of inflammatory parameters (time frame: Blood samples were taken from the patients before the surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05348070, which also lists 3 linked publications.
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 27 Apr 2022.