Inflammatory Markers in Hysterectomies

December 8, 2019 updated by: mehmet ozsurmeli

Evaluation of Inflammatory Markers in Laparoscopic and Abdominal Hysterectomies: A Retrospective Study in Kocaeli, Northwest Turkey

This retrospective study was conducted in the obstetrics and gynecology clinic at Derince Training and Research Hospital.

The study group was identified as patients who underwent hysterectomy between 2018 and 2019. Our hospital is a 50-bed tertiary reference center where approximately 3,500 births per year occur, and about 500 gynecological-oncological surgeries are performed annually. The records of patients who underwent LH and AH were reviewed retrospectively. Preoperative and postoperative blood values in the first 24 hours after surgery were compared: hematocrit (HCT), hemoglobin (HB), WBC, PLR, and NLR values were compared as well as the demographic characteristics of the patients who underwent these procedures. In addition, to evaluate the effect of ovaries on the inflammatory markers, the patients were divided into two groups: oophorectomy and non-oophorectomy.

In our clinic, the decision to perform a hysterectomy is made by the weekly gynecology council. The type of surgery is determined according to the clinical condition of the patient, the gynecological examination, and the patient's request. In general, open surgery is preferred in patients with giant fibroids, many previous surgeries, and immobile uteri. Conditions such as dysfunctional uterine bleeding, cervical intraepithelial neoplasms, and uterine descensus indicate the need for LH. In cases where there is no clinical suspicion, oophorectomy is performed according to the patients' wishes.

In benign cases, the preferred type of hysterectomy is type 1 extra facial hysterectomy. In LH, the procedure is performed as follows: The uterine manipulator is inserted vaginally. First, a Veress needle and then a trocar are entered through the umbilicus. The abdomen is insufflated with carbon dioxide, and the appropriate number of ports is placed. Uterine ligaments and vessels are cut by using bipolar energy. The uterus is removed through the vagina, and the vaginal cuff is sutured laparoscopically.

Patients with chronic diseases (e.g., hypertension, diabetes mellitus, and rheumatologic, nephrological, and hematological diseases), the presence of active infection, corticosteroid use, acetylsalicylic acid, and anticoagulant use were not included in the study. Bladder and bowel injuries, blood transfusion requirements, wound infection and hematoma, postoperative respiratory system complications (e.g., atelectasis) were evaluated as surgical complications.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

212

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Kocaeli, Turkey, 1260
        • Derince Training and Research Hospital

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

women without any other medical problem who need hysterectomy for any condition

Description

Inclusion Criteria:

  • total or abdominal hysterectomy

Exclusion Criteria:

  • hypertension, diabetes mellitus, rheumatologic, nephrological, and hematological diseases), the presence of active infection, corticosteroid use, acetylsalicylic acid, and anticoagulant use were not included in the study.

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
Total laparoscopic hysterectomies
Between 2018 and 2019, data obtained from patients in the LH and AH 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.
Abdominal hysterectomies
Between 2018 and 2019, data obtained from patients in the LH and AH 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of inflammatory markers in abdominal and laparoscopic hysterectomies
Time Frame: 24 hours post-surgery
Preoperative and postoperative hematocrit (%), hematocrit (%), hemoglobin (gram/deciliter), white blood cell (x103/mm3), PLR, and NLR values values in the first 24 hours after laparoscopic or abdominal hysterectomies were compared.
24 hours post-surgery

Collaborators and Investigators

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

Sponsor

mehmet ozsurmeli

Investigators

  • Study Director: Ünal Türkay, MD, Derince Training and Research Hospital
  • Study Chair: Bahar Salıcı, MD, Derince Training and Research Hospital
  • Study Chair: Mehmet Salıcı, MD, Derince Training and Research Hospital
  • Study Chair: Karanfil Nisan Bölge, MD, Derince Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (ACTUAL)

January 1, 2018

Primary Completion (ACTUAL)

August 31, 2019

Study Completion (ACTUAL)

September 30, 2019

Study Registration Dates

First Submitted

November 27, 2019

First Submitted That Met QC Criteria

November 30, 2019

First Posted (ACTUAL)

December 4, 2019

Study Record Updates

Last Update Posted (ACTUAL)

December 11, 2019

Last Update Submitted That Met QC Criteria

December 8, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 35753575

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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