Clinical trial NCT05348070: Comparison of Operated Ruptured and Non-ruptured Endometriomas
Official title: Comparison of Inflammatory Parameters in Operated Ruptured and Non-ruptured Endometriomas
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometrioma
Ruptured Endometrioma
Endometriosis Ovary
Keywords: endometrioma
rupture
endometriosis
Lead sponsor: EZH EAH
Sponsor class: OTHER
First posted: 2022-04-27
Enrollment: 181
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 48
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

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

Primary outcomes:
measure: Pre-interventional Comparison of inflammatory parameters
timeFrame: Blood samples were taken from the patients before the surgery
measure: Comparison of inflammatory parameters after surgery
timeFrame: Blood samples were taken from the patients in the first postoperative day.
measure: Pre-interventional Comparison of tumor markers
timeFrame: Blood samples were taken from the patients before the surgery
measure: Comparison of tumor markers after surgery
timeFrame: Blood samples were taken from the patients after the surgery up to 24 weeks
Secondary outcomes:
measure: Sexual activity
timeFrame: Before surgery
measure: Infertility
timeFrame: Before surgery
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Republic of Turkey Ministry of Health, Health Science University Etlik Zübeyde Hanım Gynecology Training and Research Hospital Infertility Clinic
state: Keçiören
Study officials:
affiliation: Etlik Zübeyde Hanım Gynecology Training and Research Hospital Infertility Clinic's Chief
name: Berna Dilbaz, Prof.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.