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NCT Number: NCT07667907

vNOTES vs Laparoscopy: Respiratory Mechanics and Hemodynamics

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.

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Key information

Age range

18 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

Bursa Yuksek Ihtisas Training and Research Hospital

Bursa, Yıldırım, 16350, Turkey (Türkiye)

Location contact

Selvinaz YÜKSEL TANRIVERDİ, MD

CONTACT

[email protected]

+90(258)2966000

About this study

This study aims to compare vNOTES (Vaginal Natural Orifice Transluminal Endoscopic Surgery) and laparoscopic gynecological surgery in terms of intraoperative respiratory mechanics and hemodynamics in patients scheduled for elective gynecological surgery.

The findings of this study will contribute to more effective planning of ventilation and hemodynamic management by anesthesiologists in vNOTES cases, the development of lung-protective ventilation protocols, and the improvement of perioperative anesthesia quality.

This study is designed as a prospective, observational, single-center, parallel-group cohort study. Patients scheduled for elective gynecological surgery will be divided into two groups according to the surgical technique: Group 1 (vNOTES, n=15) and Group 2 (Laparoscopic surgery, n=15). No randomization will be performed; the surgical technique, insufflation pressure, and Trendelenburg angle will be left to the clinician's discretion.

Measurements will be performed at four time points: T0 (10th minute after intubation, before insufflation), T1 (15th minute after pneumoperitoneum and Trendelenburg positioning), T2 (45th minute after pneumoperitoneum; or the last 5 minutes before desufflation in cases where the 45th minute is not reached), and T3 (15th minute after desufflation). At each time point, respiratory mechanics parameters (Ppeak, Pplateau, DP, MPtot, MPdyn, Crs), hemodynamic parameters (MAP, HR, vasopressor requirement), and intraoperative opioid consumption will be recorded. Insufflation pressure, Trendelenburg angle, and surgical duration will be recorded as confounding variables.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Female patients aged 18 to 75 years
  • Patients scheduled for elective gynecological surgery
  • Patients undergoing mechanical ventilation under general anesthesia
  • ASA physical status I-III
  • Patients providing written informed consent

Exclusion criteria

  • Severe or uncontrolled chronic obstructive pulmonary disease, asthma, or other chronic pulmonary diseases
  • Cardiac arrhythmia
  • ASA physical status IV or above
  • Patients developing intraoperative hemodynamic instability
  • Patients receiving spinal or epidural anesthesia
  • Cases requiring conversion to laparoscopy or laparotomy
  • Patients refusing to participate

Treatment and study plan

vNOTES (Vaginal Natural Orifice Transluminal Endoscopic Surgery

Procedure

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

Other names: Vaginal NOTES, Natural Orifice Transluminal Endoscopic Surgery

Laparoscopic Gynecological Surgery

Procedure

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

Other names: Laparoscopy

Primary outcomes

  1. Driving Pressure (DP)

    Time frame: Intraoperative (T0: 10th minute after intubation before insufflation; T1: 15th minute after pneumoperitoneum and Trendelenburg positioning; T2: 45th minute after pneumoperitoneum; T3: 15th minute after desufflation)

    Driving pressure measured at four intraoperative time points to compare the effects of vNOTES and laparoscopic gynecological surgery on respiratory mechanics.

  2. Peak Airway Pressure (Ppeak)

    Time frame: Intraoperative (T0: 10th minute after intubation before insufflation; T1: 15th minute after pneumoperitoneum and Trendelenburg positioning; T2: 45th minute after pneumoperitoneum; T3: 15th minute after desufflation)

    Peak airway pressure measured at four intraoperative time points to compare the effects of vNOTES and laparoscopic gynecological surgery on respiratory mechanics.

  3. Plateau Pressure (Pplateau)

    Time frame: Intraoperative (T0: 10th minute after intubation before insufflation; T1: 15th minute after pneumoperitoneum and Trendelenburg positioning; T2: 45th minute after pneumoperitoneum; T3: 15th minute after desufflation)

    Plateau pressure measured at four intraoperative time points to compare the effects of vNOTES and laparoscopic gynecological surgery on respiratory mechanics.

  4. Respiratory System Compliance (Crs)

    Time frame: Intraoperative (T0: 10th minute after intubation before insufflation; T1: 15th minute after pneumoperitoneum and Trendelenburg positioning; T2: 45th minute after pneumoperitoneum; T3: 15th minute after desufflation)

    Respiratory system compliance measured at four intraoperative time points to compare the effects of vNOTES and laparoscopic gynecological surgery on respiratory mechanics.

  5. Mean Arterial Pressure (MAP)

    Time frame: Intraoperative (T0: 10th minute after intubation before insufflation; T1: 15th minute after pneumoperitoneum and Trendelenburg positioning; T2: 45th minute after pneumoperitoneum; T3: 15th minute after desufflation)

    Mean arterial pressure measured at four intraoperative time points to compare the hemodynamic effects of vNOTES and laparoscopic gynecological surgery.

  6. Heart Rate (HR)

    Time frame: Intraoperative (T0: 10th minute after intubation before insufflation; T1: 15th minute after pneumoperitoneum and Trendelenburg positioning; T2: 45th minute after pneumoperitoneum; T3: 15th minute after desufflation)

    Heart rate measured at four intraoperative time points to compare the hemodynamic effects of vNOTES and laparoscopic gynecological surgery.

Secondary outcomes

  1. Mechanical Power (MPtot and MPdyn)

    Time frame: Intraoperative (T0: 10th minute after intubation before insufflation; T1: 15th minute after pneumoperitoneum and Trendelenburg positioning; T2: 45th minute after pneumoperitoneum; T3: 15th minute after desufflation)

    Total and dynamic mechanical power calculated at four intraoperative time points to assess ventilator-induced lung injury risk in vNOTES and laparoscopic gynecological surgery.

  2. Vasopressor Requirement

    Time frame: ntraoperative (from surgical start to end of surgery)

    Incidence of vasopressor use and total vasopressor dose administered intraoperatively in vNOTES and laparoscopic gynecological surgery groups.

  3. Intraoperative Opioid Consumption

    Time frame: Intraoperative (from surgical start to end of surgery)

    Cumulative total opioid consumption (fentanyl in mcg and/or remifentanil in mcg/kg/min) administered from the start of surgery to the end of surgery in vNOTES and laparoscopic gynecological surgery groups.

Study contacts

Contact information is provided by the study sponsor or research team.

Selvinaz Yüksel Tanrıverdi, MD

CONTACT

[email protected]

+0902242955000

Sponsors and collaborators

Lead sponsor

Bursa Yuksek Ihtisas Training and Research Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 25, 2026
Registry last updated
Jun 25, 2026

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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