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NCT07667907

vNOTES vs Laparoscopy: Respiratory Mechanics and Hemodynamics

Sponsor: Bursa Yuksek Ihtisas Training and Research Hospital

View on ClinicalTrials.gov

Summary

Pneumoperitoneum and Trendelenburg position are unavoidable in laparoscopic surgery and are known to have adverse effects on intraoperative respiratory mechanics and hemodynamics. These conditions increase the risk of ventilator-induced lung injury (VILI) and highlight the importance of lung-protective ventilation strategies. vNOTES (Vaginal Natural Orifice Transluminal Endoscopic Surgery) is a minimally invasive technique that requires less Trendelenburg tilt and lower insufflation pressures compared to conventional laparoscopic surgery, and may therefore offer a more favorable intraoperative profile. This prospective, observational, single-center, parallel-group cohort study aims to compare respiratory mechanics parameters (Ppeak, Pplateau, DP, MPtot, MPdyn, Crs) and hemodynamic parameters (MAP, HR, vasopressor requirement) between vNOTES (n=15) and laparoscopic gynecological surgery (n=15) groups at four intraoperative time points.

Official title: Comparison of the Effects of vNOTES and Laparoscopic Gynecological Surgery on Intraoperative Respiratory Mechanics and Hemodynamics: A Prospective Observational Cohort Study

Key Details

Gender

FEMALE

Age Range

18 Years - 75 Years

Study Type

OBSERVATIONAL

Enrollment

30

Start Date

2026-07-01

Completion Date

2027-07-01

Last Updated

2026-06-25

Healthy Volunteers

No

Interventions

PROCEDURE

vNOTES (Vaginal Natural Orifice Transluminal Endoscopic Surgery

Elective gynecological surgery performed via vaginal natural orifice transluminal endoscopic surgery with lower Trendelenburg angle and insufflation pressure compared to conventional laparoscopy.

PROCEDURE

Laparoscopic Gynecological Surgery

Conventional laparoscopic gynecological surgery performed with standard pneumoperitoneum and Trendelenburg positioning.

Locations (1)

Bursa Yuksek Ihtisas Training and Research Hospital

Bursa, Yıldırım, Turkey (Türkiye)