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New Inflammation Markers for Distinguishing Uterine Adenomyosis and Leiomyoma

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ClinicalTrials.gov Identifier: NCT02997787
Recruitment Status : Completed
First Posted : December 20, 2016
Last Update Posted : December 26, 2016
Sponsor:
Information provided by (Responsible Party):
Yusuf MADENDAG, Kayseri Education and Research Hospital

Brief Summary:

Both pelvic masses and preoperative diagnosis of them have still continued as an important investigation subject. It is important to discriminate the diagnoses of leiomyoma and adenomyosis before operation especially among infertile patients. Neoplasms can alter systemic or local immune response in their originating area.Neutrophil to lymphocyte ratio (NLR) and platelet to lymphocyte ratio (PLR) can be readily determined by using of complete blood counter test (CBC). A high NLR has been shown in systemic inflammation, some gynecologic and gastrointestinal cancers and some cardiovascular diseases.

The investigators aim to investigate using new inflammation markers, NLR and PLR, whether they are useful to discriminate between adenomyosis and leiomyoma. As far as is known, there have been no previous reports about the association among NLR, PLR, adenomyosis and leiomyoma.


Condition or disease
Adenomyosis Leiomyoma Inflammation

Detailed Description:

A retrospective cross-sectional study was conducted at the Kayseri Education and Research Hospital, Department of Obstetrics and Gynecology, Kayseri, Turkey, between January 2016 and October 2016.

Approval of the Institutional Review Board of Kayseri Erciyes University the Faculty of Medicine was obtained in advance (2016/525).

Exclusion criteria were as fallows; diabetes mellitus, metabolic disorder, acute or chronic infection disease, hypertension, acute coroner artery disease, connective tissue disorder, vasculitis, inflammatory bowel disease, tobacco and alcohol use, renal failure, hepatitis, patients using corticosteroid drug and patients underwent blood transfusion within three months. The investigators reviewed a database of 386 patients who were referred for abnormal uterine bleeding resistant to medical treatment or detected pelvic mass in postmenopausal and premenopausal period and underwent hysterectomy in our department. The investigators are capable of including 196 patients in the present study because of exclusion criteria.

There were three groups in our study. First group called adenomyosis was consisted of patients who were pathologically diagnosed pure adenomyosis after hysterectomy. Second group called leiomyoma was consisted of patients who were pathologically diagnosed pure leiomyoma after hysterectomy. Third group called control group was consisted of healthy patients who were pathologically diagnosed no neoplasm after hysterectomy.

In order to evaluate serum levels of hemoglobin, leukocytes, neutrophil, lymphocyte, platelet and CA125, the investigators obtained data analysis measured preoperatively from venous blood samples of all subjects. The NLR was defined as the absolute neutrophil count divided by the absolute lymphocyte count and the PLR was defined as the absolute platelet count divided by the absolute lymphocyte count.


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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Neutrophil to Lymphocyte Ratio and Platelet to Lymphocyte Ratio Can Be Useful Markers for Distinguishing Uterine Adenomyosis and Leiomyoma
Study Start Date : January 2016
Actual Primary Completion Date : October 2016
Actual Study Completion Date : November 2016

Group/Cohort
adenomyosis
First group called adenomyosis was consisted of patients who were pathologically diagnosed pure adenomyosis after hysterectomy
leiomyoma
Second group called leiomyoma was consisted of patients who were pathologically diagnosed pure leiomyoma after hysterectomy
control
Third group called control group was consisted of healthy patients who were pathologically diagnosed no neoplasm after hysterectomy



Primary Outcome Measures :
  1. Measured serum inflammatory markers among groups by complete blood count [ Time Frame: 3 months ]
    Those markers are neutrophil, lymphocyte and platelet count.



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Ages Eligible for Study:   35 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
There were three groups in our study. First group called adenomyosis was consisted of patients who were pathologically diagnosed pure adenomyosis after hysterectomy. Second group called leiomyoma was consisted of patients who were pathologically diagnosed pure leiomyoma after hysterectomy. Third group called control group was consisted of healthy patients who were pathologically diagnosed no neoplasm after hysterectomy.
Criteria

Inclusion Criteria:

  • 386 patients who were referred for abnormal uterine bleeding resistant to medical treatment or detected pelvic mass in postmenopausal and premenopausal period and underwent hysterectomy in our department were evaluated. However 196 of those patients were included in the present study because of exclusion criteria.

Exclusion Criteria:

  • Exclusion criteria were as fallows; diabetes mellitus, metabolic disorder, acute or chronic infection disease, hypertension, acute coroner artery disease, connective tissue disorder, vasculitis, inflammatory bowel disease, tobacco and alcohol use, renal failure, hepatitis, patients using corticosteroid drug and patients underwent blood transfusion within three months.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02997787


Sponsors and Collaborators
Kayseri Education and Research Hospital
Investigators
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Principal Investigator: Yusuf Madendag Kayseri Education and Research Hospital

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Responsible Party: Yusuf MADENDAG, Director, Kayseri Education and Research Hospital
ClinicalTrials.gov Identifier: NCT02997787     History of Changes
Other Study ID Numbers: 2016/525
First Posted: December 20, 2016    Key Record Dates
Last Update Posted: December 26, 2016
Last Verified: December 2016

Keywords provided by Yusuf MADENDAG, Kayseri Education and Research Hospital:
adenomyosis
leiomyoma
neutrophil to lymphocyte ratio
platelet to lymphocyte ratio

Additional relevant MeSH terms:
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Leiomyoma
Myofibroma
Adenomyosis
Inflammation
Pathologic Processes
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases
Uterine Diseases
Genital Diseases, Female