Predictive Value of Preoperative Evaluation in Cases of Recurrent Endometriosis

November 13, 2023 updated by: Evrim Ebru Kovalak, Bagcilar Training and Research Hospital
To investigate the effect of preoperative evaluation parameters in predicting recurrent disease in women who have undergone cystectomy or unilateral salpingo-oophorectomy due to endometriosis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Endometriosis is an estrogen-dependent gynecological disease characterized by the presence of endometrial-like tissue outside the uterine cavity, associated with pelvic pain and subfertility. Despite its benign character, endometriosis can recur after surgery and continues to be a disease that disrupts the quality of life of millions of women. This study aimed to examine the risk factors in women who underwent cystectomy or unilateral salpingo-oophorectomy due to endometriosis but had a recurrence. Therefore, the predictive value of parameters such as preoperative biochemical parameters, cyst size and the revised American Society for Reproductive Medicine (rASRM) Scoring system will be examined in recurrent cases.

Study Type

Observational

Enrollment (Estimated)

64

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
    • Bagcilar
      • Istanbul, Bagcilar, Turkey, 34200
        • Recruiting
        • Bagcilar Teaching and Research Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

All women between the ages of 18-50 who were followed up in our clinic after cystectomy or unilateral oophorectomy due to endometriosis.

Description

Inclusion Criteria:

  • Women aged 18-50 who had a cystectomy or unilateral oophorectomy due to endometriosis

Exclusion Criteria:

  • Women who have had bilateral oophorectomy due to endometriosis
  • Malignant conditions
  • Smoking
  • Women with autoimmune disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Remission group
Group of women who underwent cystectomy or unilateral oophorectomy due to endometriosis but were in remission during follow-up
Procedure: Surgery of endometriosis
Cystectomy or unilateral oophorectomy due to endometriosis
Recurrent group
Group of women who underwent cystectomy or unilateral oophorectomy due to endometriosis but developed an endometrioma of at least 2 cm in size in a single ovary during follow-up.
Procedure: Surgery of endometriosis
Cystectomy or unilateral oophorectomy due to endometriosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prediction of endometriosis recurrence
Time Frame: 6-180 months
Which women are more likely to have recurrence after endometriosis surgery?
6-180 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bagcilar Training and Research Hospital

Investigators

  • Principal Investigator: Evrim Ebru Kovalak, MD, Bagcilar Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 22, 2022

Primary Completion (Estimated)

January 1, 2024

Study Completion (Estimated)

February 1, 2024

Study Registration Dates

First Submitted

November 7, 2023

First Submitted That Met QC Criteria

November 13, 2023

First Posted (Actual)

November 15, 2023

Study Record Updates

Last Update Posted (Actual)

November 15, 2023

Last Update Submitted That Met QC Criteria

November 13, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023/05/11/030

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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