Comparison of Operated Ruptured and Non-ruptured Endometriomas

NCT ID: NCT05348070

Last Updated: 2022-04-27

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

COMPLETED

Total Enrollment

181 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-01

Study Completion Date

2021-06-20

Brief Summary

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Ruptured endometrioma cases were compared with unruptured endometrioma cases.

Detailed Description

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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

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Endometrioma Ruptured Endometrioma Endometriosis Ovary

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Laparoscopy/Laparotomy

Intervention Type PROCEDURE

All patients included in the study were operated patients.

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

Laparoscopy/Laparotomy

Intervention Type PROCEDURE

All patients included in the study were operated patients.

Interventions

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Laparoscopy/Laparotomy

All patients included in the study were operated patients.

Intervention Type PROCEDURE

Eligibility Criteria

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Exclusion Criteria

* 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
Minimum Eligible Age

16 Years

Maximum Eligible Age

48 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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EZH EAH

OTHER

Sponsor Role lead

Responsible Party

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MD. Ayşe Gülen Erturun

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Berna Dilbaz, Prof.

Role: STUDY_DIRECTOR

Etlik Zübeyde Hanım Gynecology Training and Research Hospital Infertility Clinic's Chief

Locations

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Republic of Turkey Ministry of Health, Health Science University Etlik Zübeyde Hanım Gynecology Training and Research Hospital Infertility Clinic

Ankara, Keçiören, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 26403090 (View on PubMed)

Huang 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.

Reference Type BACKGROUND
PMID: 22030044 (View on PubMed)

Tanaka 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.

Reference Type RESULT
PMID: 26166344 (View on PubMed)

Other Identifiers

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2021/76

Identifier Type: -

Identifier Source: org_study_id

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