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vNOTES vs Laparoscopy: Respiratory Mechanics and Hemodynamics

2026年6月19日 更新者:Selvinaz Yüksel Tanrıverdi、Bursa Yuksek Ihtisas Training and Research Hospital

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

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.

調査の概要

詳細な説明

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.

研究の種類

観察的

入学 (推定)

30

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

    • Yıldırım
      • Bursa、Yıldırım、トルコ(Türkiye)、16350
        • Bursa Yuksek Ihtisas Training and Research Hospital
        • コンタクト:

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

サンプリング方法

非確率サンプル

調査対象母集団

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

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

コホートと介入

グループ/コホート
介入・治療
vNOTES Group
Patients undergoing elective gynecological surgery via Vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES).
Elective gynecological surgery performed via vaginal natural orifice transluminal endoscopic surgery with lower Trendelenburg angle and insufflation pressure compared to conventional laparoscopy.
他の名前:
  • 自然開口部経管内視鏡手術
  • Vaginal NOTES
Laparoscopic Surgery Group
Patients undergoing elective gynecological surgery via conventional laparoscopic surgery.
Conventional laparoscopic gynecological surgery performed with standard pneumoperitoneum and Trendelenburg positioning.
他の名前:
  • 腹腔鏡検査

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Driving Pressure (DP)
時間枠: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.
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)
時間枠: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.
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)
時間枠: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.
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)
時間枠: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.
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)
時間枠: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.
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)
時間枠: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.
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)

二次結果の測定

結果測定
メジャーの説明
時間枠
Mechanical Power (MPtot and MPdyn)
時間枠: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.
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
時間枠: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.
ntraoperative (from surgical start to end of surgery)
Intraoperative Opioid Consumption
時間枠: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.
Intraoperative (from surgical start to end of surgery)

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研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年7月1日

一次修了 (推定)

2027年7月1日

研究の完了 (推定)

2027年7月1日

試験登録日

最初に提出

2026年6月19日

QC基準を満たした最初の提出物

2026年6月19日

最初の投稿 (実際)

2026年6月25日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月25日

QC基準を満たした最後の更新が送信されました

2026年6月19日

最終確認日

2026年6月1日

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個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

Individual participant data will not be shared due to patient confidentiality concerns.

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