New Inflammation Markers for Distinguishing Uterine Adenomyosis and Leiomyoma

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Brief Title

New Inflammation Markers for Distinguishing Uterine Adenomyosis and Leiomyoma

Official Title

Neutrophil to Lymphocyte Ratio and Platelet to Lymphocyte Ratio Can Be Useful Markers for Distinguishing Uterine Adenomyosis and Leiomyoma

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.
    

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.
    


Study Type

Observational


Primary Outcome

Measured serum inflammatory markers among groups by complete blood count


Condition

Adenomyosis


Study Arms / Comparison Groups

 adenomyosis
Description:  First group called adenomyosis was consisted of patients who were pathologically diagnosed pure adenomyosis after hysterectomy

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

60

Start Date

January 2016

Completion Date

November 2016

Primary Completion Date

October 2016

Eligibility 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.
      

Gender

Female

Ages

35 Years - 60 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Yusuf Madendag, , 



Administrative Informations


NCT ID

NCT02997787

Organization ID

2016/525


Responsible Party

Principal Investigator

Study Sponsor

Kayseri Education and Research Hospital


Study Sponsor

Yusuf Madendag, Principal Investigator, Kayseri Education and Research Hospital


Verification Date

December 2016