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

E

EZH EAH

Status

Completed

Conditions

Ruptured Endometrioma
Endometriosis Ovary
Endometrioma

Treatments

Procedure: Laparoscopy/Laparotomy

Study type

Observational

Funder types

Other

Identifiers

NCT05348070
2021/76

Details and patient eligibility

About

Ruptured endometrioma cases were compared with unruptured endometrioma cases.

Full 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.

Enrollment

181 patients

Sex

Female

Ages

16 to 48 years old

Volunteers

No Healthy Volunteers

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

Trial design

181 participants in 2 patient groups

Operated Non-Ruptured Endometrioma Group
Description:
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.
Treatment:
Procedure: Laparoscopy/Laparotomy
Operated Ruptured Endometrioma Group
Description:
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
Treatment:
Procedure: Laparoscopy/Laparotomy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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