Clinical trial NCT04184765: Inflammatory Markers in Hysterectomies
Official title: Evaluation of Inflammatory Markers in Laparoscopic and Abdominal Hysterectomies: A Retrospective Study in Kocaeli, Northwest Turkey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gynecologic Disease
Inflammation
Keywords: hysterectomies
inflammation mediators
lymphocyte
Lead sponsor: Derince Training and Research Hospital
Sponsor class: OTHER
First posted: 2019-12-04
Enrollment: 212
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women without any other medical problem who need hysterectomy for any condition

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change of inflammatory markers in abdominal and laparoscopic hysterectomies
timeFrame: 24 hours post-surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Derince Training and Research Hospital
Study officials:
affiliation: Derince Training and Research Hospital
name: Ünal Türkay, MD
role: STUDY_DIRECTOR
affiliation: Derince Training and Research Hospital
name: Bahar Salıcı, MD
role: STUDY_CHAIR
affiliation: Derince Training and Research Hospital
name: Mehmet Salıcı, MD
role: STUDY_CHAIR
affiliation: Derince Training and Research Hospital
name: Karanfil Nisan Bölge, MD
role: STUDY_CHAIR
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