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Completed

NCT Number: NCT04221308

Inflammatory Markers in Natural Orifice Hysterectomies

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.

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Key information

Conditions

Gynecologic Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases

Age range

45 year–60 year

Sex eligibility

Female

Study type

Observational

Primary location

Derince Training and Research Hospital

Kocaeli, 1260, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Single port laparoscopic systems

Device

The first assistant handles the scope from the patient's right side. The second assistant, who is positioned between the legs of the patient, inserts a uterine manipulator (Rumi System; Cooper Surgical, CT). At the beginning of the surgery, a 1.5 to 2.5 cm vertical incision is made within the umbilicus using the open Hasson approach. After the bottom retractor ring of the wound retractor component of the Octo-Port is inverted (DalimSurgNet, Seoul, Korea), it is inserted through the incision deep in the peritoneum. Carbon dioxide is insufflated through the gas valve of the Octo-Port to maintain intra-abdominal pressure at 10 to 12 mm Hg. Through the 10 mm channels of the Octo-Port, a 10 mm, 30° rigid laparoscope is introduced. Rigid laparoscopic instruments are introduced through the 5 mm channels of the Octo-Port. The utero-ovarian ligament or infundibulopelvic ligament, uterine vessels, and uterine ligaments are transected by using the 5 mm LigaSure vessel sealer device

Primary outcomes

  1. Changes in hematocrit levels

    Time frame: 1 day

    Hematocrit (%) levels in the first 24 hours after single port laparoscopic or vaginal hysterectomies were compared.

  2. Changes in hemoglobin levels

    Time frame: 1 day

    Hemoglobin levels in the first 24 hours after single port laparoscopic or vaginal hysterectomies were compared.

  3. Changes in white blood cell levels

    Time frame: 1 day

    white blood cell (x103/mm3), in the first 24 hours after single port laparoscopic or vaginal hysterectomies were compared.

  4. Changes in neutrophil-lymphocyte and platelet-lymphocyte ratio

    Time frame: 1 day

    neutrophil-lymphocyte and platelet-lymphocyte ratio in the first 24 hours after single port laparoscopic or vaginal hysterectomies were compared.

Sponsors and collaborators

Lead sponsor

Derince Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 9, 2020
Registry last updated
Jan 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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