EndometriosisNCT06132009
Predictive Value of Preoperative Evaluation in Cases of Recurrent Endometriosis
An observational study of Endometriosis, run by Bagcilar Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
To investigate the effect of preoperative evaluation parameters in predicting recurrent disease in women who have undergone cystectomy or unilateral salpingo-oophorectomy due to endometriosis. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- Surgery of endometriosis
- Type of treatment
- Surgery or procedure
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Feb 2022to 1 Feb 2024
- 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 18 to 50 years
- Women only
- Adult
Study population: All women between the ages of 18-50 who were followed up in our clinic after cystectomy or unilateral oophorectomy due to endometriosis.
Who may be able to join
- Women aged 18-50 who had a cystectomy or unilateral oophorectomy due to endometriosis
Who cannot join
- Women who have had bilateral oophorectomy due to endometriosis
- Malignant conditions
- Smoking
- Women with autoimmune disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bagcilar Teaching and Research Hospital
Istanbul, Bagcilar, 34200
Evrim Ebru Kovalak, MD, +905324628989, evrimebru@yahoo.com
About this study
To investigate the effect of preoperative evaluation parameters in predicting recurrent disease in women who have undergone cystectomy or unilateral salpingo-oophorectomy due to endometriosis.
Read the detailed description
Endometriosis is an estrogen-dependent gynecological disease characterized by the presence of endometrial-like tissue outside the uterine cavity, associated with pelvic pain and subfertility. Despite its benign character, endometriosis can recur after surgery and continues to be a disease that disrupts the quality of life of millions of women. This study aimed to examine the risk factors in women who underwent cystectomy or unilateral salpingo-oophorectomy due to endometriosis but had a recurrence. Therefore, the predictive value of parameters such as preoperative biochemical parameters, cyst size and the revised American Society for Reproductive Medicine (rASRM) Scoring system will be examined in recurrent cases.
- Conditions
- Endometriosis
- Being tested
- Surgery of endometriosis
- Keywords
- Endometriosis, prevention & control, preoperative procedures
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery of endometriosisProcedure or surgery
Cystectomy or unilateral oophorectomy due to endometriosis
| Study group | Role | What they receive |
|---|---|---|
| Remission group | Group of women who underwent cystectomy or unilateral oophorectomy due to endometriosis but were in remission during follow-up Receives: Procedure: Surgery of endometriosis | |
| Recurrent group | Group of women who underwent cystectomy or unilateral oophorectomy due to endometriosis but developed an endometrioma of at least 2 cm in size in a single ovary during follow-up. Receives: Procedure: Surgery of endometriosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction of endometriosis recurrence
Which women are more likely to have recurrence after endometriosis surgery?
Measured: 6-180 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start22 Feb 2022
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bagcilar Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Evrim Ebru Kovalak, Bagcilar Training and Research Hospital
- Investigators
- Evrim Ebru Kovalak, MD, Principal investigator, Bagcilar Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06132009
- Sponsor's protocol ID
- 2023/05/11/030
- Status last verified
- Nov 2023
- First submitted
- 7 Nov 2023
- Last updated
- 15 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hidari T, Hirata T, Arakawa T, Koga K, Neriishi K, Fukuda S, Nakazawa A, Nagashima N, Ma S, Sun H, Takamura M, Harada M, Hirota Y, Wada-Hiraike O, Fujii T, Osuga Y. Contralateral ovarian endometrioma recurrence after unilateral salpingo-oophorectomy. BMC Womens Health. 2019 May 2;19(1):59. doi: 10.1186/s12905-019-0760-z.
PubMed 31046768
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Preoperative Evaluation in Cases of Recurrent Endometriosis
- ClinicalTrials.gov ID
- NCT06132009
- Acronym / sponsor ID
- 2023/05/11/030
- Conditions
- Endometriosis
- Keywords
- Endometriosis, prevention & control, preoperative procedures
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Bagcilar Training and Research HospitalOther government
- Study start
- 22 Feb 2022 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 15 Nov 2023 (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.
To investigate the effect of preoperative evaluation parameters in predicting recurrent disease in women who have undergone cystectomy or unilateral salpingo-oophorectomy due to endometriosis.
Detailed description
Endometriosis is an estrogen-dependent gynecological disease characterized by the presence of endometrial-like tissue outside the uterine cavity, associated with pelvic pain and subfertility. Despite its benign character, endometriosis can recur after surgery and continues to be a disease that disrupts the quality of life of millions of women. This study aimed to examine the risk factors in women who underwent cystectomy or unilateral salpingo-oophorectomy due to endometriosis but had a recurrence. Therefore, the predictive value of parameters such as preoperative biochemical parameters, cyst size and the revised American Society for Reproductive Medicine (rASRM) Scoring system will be examined in recurrent cases.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remission group | – | Procedure: Surgery of endometriosisGroup of women who underwent cystectomy or unilateral oophorectomy due to endometriosis but were in remission during follow-up |
| Recurrent group | – | Procedure: Surgery of endometriosisGroup of women who underwent cystectomy or unilateral oophorectomy due to endometriosis but developed an endometrioma of at least 2 cm in size in a single ovary during follow-up. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- All women between the ages of 18-50 who were followed up in our clinic after cystectomy or unilateral oophorectomy due to endometriosis.
Key inclusion criteria (1 listed)
- Women aged 18-50 who had a cystectomy or unilateral oophorectomy due to endometriosis
Key exclusion criteria (4 listed)
- Women who have had bilateral oophorectomy due to endometriosis
- Malignant conditions
- Smoking
- Women with autoimmune disease
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 |
|---|---|---|
| Surgery of endometriosisCystectomy or unilateral oophorectomy due to endometriosis | Procedure or surgery | Recurrent group, Remission group |
Primary outcome
Prediction of endometriosis recurrence
Time frame: 6-180 months
Which women are more likely to have recurrence after endometriosis surgery?
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
- Results publication: PubMed 31046768Hidari T, Hirata T, Arakawa T, Koga K, Neriishi K, Fukuda S, Nakazawa A, Nagashima N, Ma S, Sun H, Takamura M, Harada M, Hirota Y, Wada-Hiraike O, Fujii T, Osuga Y. Contralateral ovarian endometrioma recurrence after unilateral salpingo-oophorectomy. BMC Womens Health. 2019 May 2;19(1):59. doi: 10.1186/s12905-019-0760-z.
- Hidari T, Hirata T, Arakawa T, Koga K, Neriishi K, Fukuda S, Nakazawa A, Nagashima N, Ma S, Sun H, Takamura M, Harada M, Hirota Y, Wada-Hiraike O, Fujii T, Osuga Y. Contralateral ovarian endometrioma recurrence after unilateral salpingo-oophorectomy.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Evrim Ebru Kovalak, MD principal investigator
Bagcilar Training and Research Hospital
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 Endometriosis, run by Bagcilar Training and Research Hospital 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: status not confirmed, as of the sponsor's last update on 15 Nov 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Evrim Ebru Kovalak, MD (905324628989, evrimebru@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prediction of endometriosis recurrence (time frame: 6-180 months). 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 NCT06132009, which also lists 1 linked publication.
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 15 Nov 2023.