Inflammatory Markers in Hysterectomies

NCT04184765 | Completed

• 1 other identifier: 35753575
• Study Type: observational
• Target: 212
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gynecologic Disease; Inflammation

Keywords

hysterectomies; inflammation mediators; lymphocyte

Outcome Measures

Primary Outcomes (1)

• Change of inflammatory markers in abdominal and laparoscopic hysterectomies

  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

Study Arms (2)

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.

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• total or abdominal hysterectomy

You may not qualify if:

• 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.

Sponsors & Collaborators

• mehmet ozsurmeli: lead

Study Sites (1)

Derince Training and Research Hospital

Kocaeli, 1260, Turkey (Türkiye)

Location

Related Publications (34)

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  PMID: 29338159 RESULT

• Ozsurmeli M, Turkay U, Salici B, Salici M, Bolge KN, Terzi H. Evaluation of inflammatuar response in hysterectomies: a retrospective study in Kocaeli, Turkey. Ginekol Pol. 2021;92(2):105-109. doi: 10.5603/GP.a2020.0146. Epub 2021 Jan 15.

  PMID: 33448002 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Maternal venous blood samples were taken into hemogram tubes with 2-2.5 ml ethylenediaminetetraacetic acid (EDTA) and homogenized. The calibrations of the device were completed and analyzed using the Pentra DF Nexus Hematology System® (Horiba Healthcare, Japan). PLR and NLR were calculated by dividing platelet and neutrophil counts, respectively, by the lymphocyte count.

MeSH Terms

Conditions

Genital Diseases, Female; Inflammation

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ünal Türkay, MD

  Derince Training and Research Hospital

  STUDY DIRECTOR

• 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

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: medical doctor

Study Record Dates

• First Submitted: November 27, 2019
• First Posted: December 4, 2019
• Study Start: January 1, 2018
• Primary Completion: August 31, 2019
• Study Completion: September 30, 2019
• Last Updated: December 11, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)