vNOTES vs Laparoscopy: Respiratory Mechanics and Hemodynamics
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-75
SponsorBursa Yuksek Ihtisas Training and Research Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Adult female patients aged 18-75 years scheduled for elective gynecological surgery under general anesthesia.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
vNOTES (Vaginal Natural Orifice Transluminal Endoscopic Surgery
Procedure/SurgeryElective gynecological surgery performed via vaginal natural orifice transluminal endoscopic surgery with lower Trendelenburg angle and insufflation pressure compared to conventional laparoscopy.
Laparoscopic Gynecological Surgery
Procedure/SurgeryConventional laparoscopic gynecological surgery performed with standard pneumoperitoneum and Trendelenburg positioning.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: vNOTES Group1 intervention
Group B: Laparoscopic Surgery Group1 intervention
Trial outcomes
Primary outcomes
1
Driving Pressure (DP)
Driving pressure measured at four intraoperative time points to compare the effects of vNOTES and laparoscopic gynecological surgery on respiratory mechanics.
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)2
Peak Airway Pressure (Ppeak)
Peak airway pressure measured at four intraoperative time points to compare the effects of vNOTES and laparoscopic gynecological surgery on respiratory mechanics.
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)3
Plateau Pressure (Pplateau)
Plateau pressure measured at four intraoperative time points to compare the effects of vNOTES and laparoscopic gynecological surgery on respiratory mechanics.
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)4
Respiratory System Compliance (Crs)
Respiratory system compliance measured at four intraoperative time points to compare the effects of vNOTES and laparoscopic gynecological surgery on respiratory mechanics.
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)Secondary outcomes
1
Mechanical Power (MPtot and MPdyn)
Total and dynamic mechanical power calculated at four intraoperative time points to assess ventilator-induced lung injury risk in vNOTES and laparoscopic gynecological surgery.
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)2
Vasopressor Requirement
Incidence of vasopressor use and total vasopressor dose administered intraoperatively in vNOTES and laparoscopic gynecological surgery groups.
Time frame
ntraoperative (from surgical start to end of surgery)3
Intraoperative Opioid Consumption
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.
Time frame
Intraoperative (from surgical start to end of surgery)Sponsors and contacts
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Source ClinicalTrials.gov
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