Predictive Value of Preoperative Evaluation in Cases of Recurrent Endometriosis

NCT ID: NCT06132009

Last Updated: 2023-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

64 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-22

Study Completion Date

2024-02-01

Brief Summary

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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

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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

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Endometriosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Remission group

Group of women who underwent cystectomy or unilateral oophorectomy due to endometriosis but were in remission during follow-up

Surgery of endometriosis

Intervention Type PROCEDURE

Cystectomy or unilateral oophorectomy due to 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.

Surgery of endometriosis

Intervention Type PROCEDURE

Cystectomy or unilateral oophorectomy due to endometriosis

Interventions

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Surgery of endometriosis

Cystectomy or unilateral oophorectomy due to endometriosis

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Women aged 18-50 who had a cystectomy or unilateral oophorectomy due to endometriosis

Exclusion Criteria

* Women who have had bilateral oophorectomy due to endometriosis
* Malignant conditions
* Smoking
* Women with autoimmune disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Bagcilar Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Evrim Ebru Kovalak

Medical Doctor, gynecologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Evrim Ebru Kovalak, MD

Role: PRINCIPAL_INVESTIGATOR

Bagcilar Training and Research Hospital

Locations

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Bagcilar Teaching and Research Hospital

Istanbul, Bagcilar, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Evrim Ebru Kovalak, MD

Role: CONTACT

905324628989

Facility Contacts

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Evrim Ebru Kovalak, MD

Role: primary

+905324628989

References

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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.

Reference Type RESULT
PMID: 31046768 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Related Links

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https://doi.org/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.

Other Identifiers

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2023/05/11/030

Identifier Type: -

Identifier Source: org_study_id

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