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CompletedNCT02997787Updated Dec 26, 2016

New Inflammation Markers for Distinguishing Uterine Adenomyosis and Leiomyoma

An observational study in Adenomyosis, Leiomyoma and Inflammation, sponsored by Kayseri Education and Research Hospital. Completed. Open to female participants aged 35 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-12-26.

Sponsored by Kayseri Education and Research Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
60
Ages
35 Years to 60 Years
Sex
Female
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Study 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.

Read the 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.

02

Conditions studied

  • Adenomyosis
  • Leiomyoma
  • Inflammation

Keywords

  • adenomyosis
  • leiomyoma
  • neutrophil to lymphocyte ratio
  • platelet to lymphocyte ratio
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In context

Adenomyosis

138 studies on the registry are indexed under Adenomyosis; 50 are open to participants now.

This study's enrollment of 60 is below the median of 150 across 57 observational studies indexed under Adenomyosis.

Browse Adenomyosis studies →

Lead sponsor

Kayseri Education and Research Hospital is the lead sponsor of 27 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
35 Years to 60 Years
Sexes eligible
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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:

  • 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.
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
60 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. Measured serum inflammatory markers among groups by complete blood count

    Those markers are neutrophil, lymphocyte and platelet count.

    Time frame: 3 months

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Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 26, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02997787
Lead sponsor
Kayseri Education and Research Hospital
Responsible party
Yusuf MADENDAG (Director, Kayseri Education and Research Hospital) — Principal investigator
First posted
Dec 20, 2016
Start date
Jan 2016
Primary completion
Oct 2016
Completion
Nov 2016
Last update
Dec 26, 2016

Study contacts

Yusuf Madendag
principal investigator · Kayseri Education and Research Hospital
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.

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