Comparison of Thyroid Volumes in Patients With and Without Endometrioma
1 other identifier
interventional
60
1 country
1
Brief Summary
The aim of our study is to evaluate whether there is a statistical difference between thyroid gland volume in patients with pathological diagnosis of endometriosis or endometrioma and in patients who underwent surgery for other gynecological reasons, and to reveal the presence of concomitant thyroid disease in these cases.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 20, 2021
CompletedFirst Submitted
Initial submission to the registry
April 5, 2022
CompletedFirst Posted
Study publicly available on registry
April 12, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 20, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 20, 2022
CompletedAugust 1, 2023
July 1, 2023
8 months
April 5, 2022
July 28, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Measuring Thyroid Volumes by ultrasonography
Longitudinal and transverse scans are performed allowing the measurement of the depth, the width and the length of each lobe. The ellipsoid formula is used. The thyroid volume is the sum of the both lobes excluding isthmus. All measurements are performed bt one experienced radiologist.
6 months
Study Arms (2)
Patients with endometrioma
ACTIVE COMPARATORPatients having a prediagnosis of surgically planned endometrioma occured this group.
Control group
ACTIVE COMPARATORPatients who had planned gynecological surgery for a reason (ovarian cycts) other than endometrioma
Interventions
The inclusion criteria are ; having a prediagnosis of surgically planned endometrioma and to undergo gynecological surgery for a reason other than endometriosis (control group). Among the patients with pre-diagnosis of endometriosis, who applied to our clinic during the study period and accepted to participate in the study, thyroid volumes will be measured by ultrasonography during the preoperative hospitalization. The pathological diagnosis of the patients will be confirmed and patients with different results will be excluded from the study (such as malignancy, endometriosis prediagnosis but different pathology detected etc.) In the same period, gynecological surgery was planned for another reason and patients without endometriosis will form the control group.
Eligibility Criteria
You may qualify if:
- Prediagnosis of surgically planned endometrioma
You may not qualify if:
- Patients with goiteri,
- Patients with past or present autoimmune thyroid dysfunction,
- Patietns on treatment with thyroid hormones or drugs containing iodine.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Adana City Education and Research Hospital
Adana, Merkez, 01100, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gulsum Uysal
University of Heath and Sciences Adana City Training and Research Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor Gulsum Uysal
Study Record Dates
First Submitted
April 5, 2022
First Posted
April 12, 2022
Study Start
September 20, 2021
Primary Completion
May 20, 2022
Study Completion
July 20, 2022
Last Updated
August 1, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share