NCT04221308

Inflammatory Markers in Natural Orifice Hysterectomies

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 134 (actual)
• Sponsor: Derince Training and Research Hospital · Academic / Other
• Sex: Female
• Age: 45 Years – 60 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Single port laparoscopic systems	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

Timeline

• Start date: 2018-01-01
• Primary completion: 2019-11-30
• Completion: 2019-12-15
• First posted: 2020-01-09
• Last updated: 2020-01-09

Locations

1 site across 1 country: Turkey (Türkiye)

Regulatory

• FDA-regulated device study