New Inflammation Markers for Distinguishing Uterine Adenomyosis and Leiomyoma

December 23, 2016 updated by: Yusuf MADENDAG, Kayseri Education and Research Hospital

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

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.

Study Overview

Status

Completed

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

Enrollment (Actual)

60

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

35 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

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.

Description

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.

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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measured serum inflammatory markers among groups by complete blood count
Time Frame: 3 months
Those markers are neutrophil, lymphocyte and platelet count.
3 months

Collaborators and Investigators

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

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

January 1, 2016

Primary Completion (ACTUAL)

October 1, 2016

Study Completion (ACTUAL)

November 1, 2016

Study Registration Dates

First Submitted

December 16, 2016

First Submitted That Met QC Criteria

December 16, 2016

First Posted (ESTIMATE)

December 20, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

December 26, 2016

Last Update Submitted That Met QC Criteria

December 23, 2016

Last Verified

December 1, 2016

More Information

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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