Not Yet RecruitingNot Applicable

vNOTES vs Laparoscopy: Respiratory Mechanics and Hemodynamics

Turkey (Türkiye)30 participantsStarted 2026-07-01

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Driving Pressure (DP)

Timeframe: 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 (Ppeak)

Plateau Pressure (Pplateau)

Respiratory System Compliance (Crs)

Mean Arterial Pressure (MAP)

Trial details

NCT IDNCT07667907

SponsorBursa Yuksek Ihtisas Training and Research Hospital

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2027-07-01

Contact for this trial

Selvinaz Yüksel Tanrıverdi, MD

+0902242955000 yukselselvinaz@gmail.com

View on ClinicalTrials.gov More Respiratory Mechanics trials