Comparison of Operated Ruptured and Non-ruptured Endometriomas (RupturedOMA)

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

Ruptured endometrioma cases were compared with unruptured endometrioma cases.

Study Overview

• Status: Completed
• Conditions: Endometrioma; Endometriosis Ovary; Ruptured Endometrioma
• Intervention / Treatment: Procedure: Laparoscopy/Laparotomy

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.

• Study Type: Observational
• Enrollment (Actual): 181

Contacts and Locations

Study Locations

• Turkey
  • Keçiören
    • Ankara, Keçiören, Turkey, 06050
      • Republic of Turkey Ministry of Health, Health Science University Etlik Zübeyde Hanım Gynecology Training and Research Hospital Infertility Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 48 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Procedure: Laparoscopy/Laparotomy; 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	Procedure: Laparoscopy/Laparotomy; All patients included in the study were operated patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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.
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sexual activity	The existence of sexual activity in each study group was questioned.	Before surgery
Infertility	The existence of infertility in each study group was questioned.	Before surgery

Collaborators and Investigators

• Sponsor: EZH EAH
• Investigators: Study Director: Berna Dilbaz, Prof., Etlik Zübeyde Hanım Gynecology Training and Research Hospital Infertility Clinic's Chief

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): June 20, 2021

Study Registration Dates

• First Submitted: January 25, 2022
• First Submitted That Met QC Criteria: April 21, 2022
• First Posted (Actual): April 27, 2022

Study Record Updates

• Last Update Posted (Actual): April 27, 2022
• Last Update Submitted That Met QC Criteria: April 21, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: endometriosis; endometrioma; rupture
• Additional Relevant MeSH Terms: Endometriosis
• Other Study ID Numbers: 2021/76

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No