New Inflammation Markers for Distinguishing Uterine Adenomyosis and Leiomyoma

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02997787
• Other study ID #: 2016/525
• Status: Completed
• Phase: N/A
• First received: December 16, 2016
• Last updated: December 23, 2016
• Start date: January 2016
• Est. completion date: November 2016

Study information

• Verified date: December 2016
• Source: Kayseri Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 60 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Adenomyosis
• Inflammation
• Leiomyoma

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kayseri Education and Research Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measured serum inflammatory markers among groups by complete blood count	Those markers are neutrophil, lymphocyte and platelet count.	3 months	No