Inflammatory Markers in Natural Orifice Hysterectomies

NCT04221308 | Completed FDA Device

• 1 other identifier: 23068423
• Study Type: observational
• Target: 134
• Locations: 1 country
• Sites: 1

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.

Conditions

Gynecologic Disease; Inflammation

Keywords

inflammation mediators; lymphocyte activation; natural orifice endoscopic surgery; neutrophil activation; platelet activation; vaginal hysterectomy

Outcome Measures

Primary Outcomes (4)

• Changes in hematocrit levels

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

  1 day

• Changes in hemoglobin levels

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

  1 day

• Changes in white blood cell levels

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

  1 day

• Changes in neutrophil-lymphocyte and platelet-lymphocyte ratio

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

  1 day

Study Arms (2)

single port laparoscopic hysterectomies

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.

Device: Single port laparoscopic systems

Vaginal hysterectomies

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.

Interventions

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

single port laparoscopic hysterectomies

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• hysterectomy requirement with any conditions in gynecologic diseases

You may not qualify if:

• 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

Sponsors & Collaborators

• Derince Training and Research Hospital: lead

Study Sites (1)

Derince Training and Research Hospital

Kocaeli, 1260, Turkey (Türkiye)

Location

Related Publications (33)

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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

• mehmet ozsurmeli

  Derince Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 1, 2020
• First Posted: January 9, 2020
• Study Start: January 1, 2018
• Primary Completion: November 30, 2019
• Study Completion: December 15, 2019
• Last Updated: January 9, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)