Comparison of Operated Ruptured and Non-ruptured Endometriomas

NCT05348070 | Completed

• 1 other identifier: 2021/76
• Study Type: observational
• Target: 181
• Locations: 1 country
• Sites: 1

Brief Summary

Ruptured endometrioma cases were compared with unruptured endometrioma cases.

Conditions

Endometrioma; Ruptured Endometrioma; Endometriosis Ovary

Keywords

endometrioma; rupture; endometriosis

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Sexual activity

  Before surgery

• Infertility

  Before surgery

Study Arms (2)

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

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

Interventions

Laparoscopy/Laparotomy PROCEDURE

All patients included in the study were operated patients.

Operated Non-Ruptured Endometrioma Group; Operated Ruptured Endometrioma Group

Eligibility Criteria

• Age: 16 Years - 48 Years
• Gender Eligibility Details: The research was conducted on female patients.
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• EZH EAH: lead

Study Sites (1)

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

Ankara, Keçiören, 06050, Turkey (Türkiye)

Location

Related 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.

  PMID: 26403090 BACKGROUND

• 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.

  PMID: 22030044 BACKGROUND

• 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.

  PMID: 26166344 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

all patients who were operated for endometrioma and had a histopathology report confirming the presence of endometrioma Surgical materials were biospecimens, which had a histopathology report confirming the presence of endometrioma

MeSH Terms

Conditions

Endometriosis; Rupture

Interventions

Laparoscopy; Laparotomy

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Berna Dilbaz, Prof.

  Etlik Zübeyde Hanım Gynecology Training and Research Hospital Infertility Clinic's Chief

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 25, 2022
• First Posted: April 27, 2022
• Study Start: January 1, 2014
• Primary Completion: December 31, 2020
• Study Completion: June 20, 2021
• Last Updated: April 27, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)