Clinical trial NCT04221308: Inflammatory Markers in Natural Orifice Hysterectomies
Official title: Evaluation of Inflammatory Markers in Single Port Laparoscopic and Vaginal Hysterectomies: A Retrospective Study in Kocaeli, Northwest Turkey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gynecologic Disease
Inflammation
Keywords: inflammation mediators
lymphocyte activation
natural orifice endoscopic surgery
neutrophil activation
platelet activation
vaginal hysterectomy
Lead sponsor: Derince Training and Research Hospital
Sponsor class: OTHER
First posted: 2020-01-09
Enrollment: 134
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women without any other medical problem who need hysterectomy for any condition

Brief summary: The authors aimed to detect inflammatory marker changes in two natural orifice hysterectomies: single-port laparoscopic hysterectomy (SLH) and vaginal hysterectomy (VH).

Between 2018 and 2019, data obtained from patients in the SLH and VH groups were reviewed retrospectively. The preoperative and postoperative hematocrit (HCT), hemoglobin (HB), white blood cell (WBC), platelet (PLR), and neutrophil-lymphocyte (NLR) ratios and values were compared as well as the demographic characteristics of the patients.


Eligibility criteria: Inclusion Criteria:

* hysterectomy requirement with any conditions in gynecologic diseases

Exclusion Criteria:

* patients with a chronic disease (e.g., hypertension, diabetes mellitus, and rheumatologic, nephrological, and hematological diseases)
* the presence of active infection
* using of corticosteroid, acetylsalicylic acid, or anticoagulant
* cystocele or rectocele repair with mesh

Primary outcomes:
measure: Changes in hematocrit levels
timeFrame: 1 day
measure: Changes in hemoglobin levels
timeFrame: 1 day
measure: Changes in white blood cell levels
timeFrame: 1 day
measure: Changes in neutrophil-lymphocyte and platelet-lymphocyte ratio
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Derince Training and Research Hospital
Study officials:
affiliation: Derince Training and Research Hospital
name: mehmet ozsurmeli
role: PRINCIPAL_INVESTIGATOR
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