vNOTES vs Laparoscopy: Respiratory Mechanics and Hemodynamics

NCT07667907 | Not Yet Recruiting

• 1 other identifier: BursaYIERHTanriverdi-001
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Respiratory Mechanics; Hemodynamics

Keywords

vNOTES; Laparoscopy; Respiratory Mechanics; Hemodynamics; Pneumoperitoneum; Trendelenburg

Outcome Measures

Primary Outcomes (6)

• Driving Pressure (DP)

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

  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)

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

  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 (Pplateau)

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

  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 (Crs)

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

  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 (MAP)

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

  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 (HR)

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

  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 (3)

• Mechanical Power (MPtot and MPdyn)

  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)

• Vasopressor Requirement

  ntraoperative (from surgical start to end of surgery)

• Intraoperative Opioid Consumption

  Intraoperative (from surgical start to end of surgery)

Study Arms (2)

vNOTES Group

Patients undergoing elective gynecological surgery via Vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES).

Procedure: vNOTES (Vaginal Natural Orifice Transluminal Endoscopic Surgery

Laparoscopic Surgery Group

Patients undergoing elective gynecological surgery via conventional laparoscopic surgery.

Procedure: Laparoscopic Gynecological Surgery

Interventions

Laparoscopic Gynecological Surgery PROCEDURE

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

Also known as: Laparoscopy

Laparoscopic Surgery Group

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.

Also known as: Vaginal NOTES, Natural Orifice Transluminal Endoscopic Surgery

vNOTES Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult female patients aged 18-75 years scheduled for elective gynecological surgery under general anesthesia.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bursa Yuksek Ihtisas Training and Research Hospital: lead

Study Sites (1)

Bursa Yuksek Ihtisas Training and Research Hospital

Bursa, Yıldırım, 16350, Turkey (Türkiye)

Location

Related Publications (3)

• Tontu F, Akca H, Berktas CK, Asar S, Ozcan FG. The impact of pneumoperitoneum and steep Trendelenburg positioning on novel oxygenation and saturation indices in robot-assisted laparoscopic prostatectomies: A prospective observational study. Saudi J Anaesth. 2025 Jul-Sep;19(3):271-276. doi: 10.4103/sja.sja_600_24. Epub 2025 Jun 16.

  PMID: 40642630 RESULT

• Neto AS, Hemmes SN, Barbas CS, Beiderlinden M, Fernandez-Bustamante A, Futier E, Gajic O, El-Tahan MR, Ghamdi AA, Gunay E, Jaber S, Kokulu S, Kozian A, Licker M, Lin WQ, Maslow AD, Memtsoudis SG, Reis Miranda D, Moine P, Ng T, Paparella D, Ranieri VM, Scavonetto F, Schilling T, Selmo G, Severgnini P, Sprung J, Sundar S, Talmor D, Treschan T, Unzueta C, Weingarten TN, Wolthuis EK, Wrigge H, Amato MB, Costa EL, de Abreu MG, Pelosi P, Schultz MJ; PROVE Network Investigators. Association between driving pressure and development of postoperative pulmonary complications in patients undergoing mechanical ventilation for general anaesthesia: a meta-analysis of individual patient data. Lancet Respir Med. 2016 Apr;4(4):272-80. doi: 10.1016/S2213-2600(16)00057-6. Epub 2016 Mar 4.

  PMID: 26947624 RESULT

• Sarikaya S, Taskin MI, Bozhuyuk Sahin T, Guney G, Kececioglu M, Afsar S, Guney SS. Comparison of Perioperative Outcomes Between V-NOTES and Total Laparoscopic Hysterectomy: A Retrospective Analysis. J Invest Surg. 2025 Dec;38(1):2488131. doi: 10.1080/08941939.2025.2488131. Epub 2025 May 1.

  PMID: 40313045 RESULT

MeSH Terms

Conditions

Pneumoperitoneum

Interventions

Natural Orifice Endoscopic Surgery; Laparoscopy

Condition Hierarchy (Ancestors)

Peritoneal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Selvinaz Yüksel Tanrıverdi, MD

CONTACT

+0902242955000; yukselselvinaz@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: June 19, 2026
• First Posted: June 25, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: June 25, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)