New Inflammation Markers for Distinguishing Uterine Adenomyosis and Leiomyoma

NCT ID: NCT02997787

Last Updated: 2016-12-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2016-11-30

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.

Conditions

Adenomyosis; Leiomyoma; Inflammation

Keywords

adenomyosis; leiomyoma; neutrophil to lymphocyte ratio; platelet to lymphocyte ratio

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

adenomyosis

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

No interventions assigned to this group

leiomyoma

Second group called leiomyoma was consisted of patients who were pathologically diagnosed pure leiomyoma after hysterectomy

No interventions assigned to this group

control

Third group called control group was consisted of healthy patients who were pathologically diagnosed no neoplasm after hysterectomy

No interventions assigned to this group

Eligibility Criteria

Inclusion 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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Kayseri Education and Research Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Yusuf MADENDAG

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yusuf Madendag

Role: PRINCIPAL_INVESTIGATOR

Kayseri Education and Research Hospital

Other Identifiers

2016/525

Identifier Type: -

Identifier Source: org_study_id