Comparison of Operated Ruptured and Non-ruptured Endometriomas

Endometrioma Clinical Trial

— RupturedOMA  

Official title:

Comparison of Inflammatory Parameters in Operated Ruptured and Non-ruptured Endometriomas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05348070
• Other study ID #: 2021/76
• Status: Completed
• Start date: January 1, 2014
• Est. completion date: June 20, 2021

Study information

• Verified date: April 2022
• Source: EZH EAH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Ruptured endometrioma cases were compared with unruptured endometrioma cases.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 181
• Est. completion date: June 20, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 48 Years

Eligibility

Inclusion Criteria:

• All patients who were operated on in Republic of Turkey Ministry of Health, Health Science University Etlik Zübeyde Hanim 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

Related Conditions & MeSH terms

• Endometrioma
• Endometriosis
• Endometriosis Ovary

Intervention

Procedure:
• Laparoscopy/Laparotomy
All patients included in the study were operated patients.

Locations

Country	Name	City	State
Turkey	Republic of Turkey Ministry of Health, Health Science University Etlik Zübeyde Hanim Gynecology Training and Research Hospital Infertility Clinic	Ankara	Keçiören

Sponsors (1)

Lead Sponsor	Collaborator
EZH EAH

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View 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. — View 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.201 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Blood samples were taken from the patients before the surgery
Primary	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	Blood samples were taken from the patients in the first postoperative day.
Primary	Pre-interventional Comparison of tumor markers	Cancer antigens; CA125, CA19-9 and CA 15-3 were compared between two groups in the preoperative period	Blood samples were taken from the patients before the surgery
Primary	Comparison of tumor markers after surgery	Cancer antigens; CA125, CA19-9 and CA 15-3 were compared between two groups in the postoperative period	Blood samples were taken from the patients after the surgery up to 24 weeks
Secondary	Sexual activity	The existence of sexual activity in each study group was questioned.	Before surgery
Secondary	Infertility	The existence of infertility in each study group was questioned.	Before surgery