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Completed

NCT Number: NCT05348070

Comparison of Operated Ruptured and Non-ruptured Endometriomas

Ruptured endometrioma cases were compared with unruptured endometrioma cases.

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Key information

Conditions

Endometrioma Endometriosis Endometriosis Ovary Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Rupture Ruptured Endometrioma Urogenital Diseases Wounds and Injuries

Age range

16 year–48 year

Sex eligibility

Female

Study type

Observational

Primary location

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

Ankara, Keçiören, 06050, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laparoscopy/Laparotomy

Procedure

All patients included in the study were operated patients.

Primary outcomes

  1. Pre-interventional Comparison of inflammatory parameters

    Time frame: Blood samples were taken from the patients before the surgery

    Neutrophil/Lymphocyte ratio (NLR), Platelet/Lymphocyte ratio (PLR), Monocyte/Lymphocyte ratio (MLR) were compared between two groups in the preoperative period

  2. Comparison of inflammatory parameters after surgery

    Time frame: Blood samples were taken from the patients in the first postoperative day.

    Neutrophil/Lymphocyte ratio (NLR), Platelet/Lymphocyte ratio (PLR), Monocyte/Lymphocyte ratio (MLR) were compared between two groups in the postoperative period

  3. Pre-interventional Comparison of tumor markers

    Time frame: Blood samples were taken from the patients before the surgery

    Cancer antigens; CA125, CA19-9 and CA 15-3 were compared between two groups in the preoperative period

  4. Comparison of tumor markers after surgery

    Time frame: Blood samples were taken from the patients after the surgery up to 24 weeks

    Cancer antigens; CA125, CA19-9 and CA 15-3 were compared between two groups in the postoperative period

Secondary outcomes

  1. Sexual activity

    Time frame: Before surgery

    The existence of sexual activity in each study group was questioned.

  2. Infertility

    Time frame: Before surgery

    The existence of infertility in each study group was questioned.

Sponsors and collaborators

Lead sponsor

EZH EAH

Other

Registry information

Official study title

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

Acronym: RupturedOMA

Important dates

Study start
2014
Primary completion
2020
Study completion
2021
First posted
Apr 27, 2022
Registry last updated
Apr 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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