Skip to main content
Top
Published in: BMC Anesthesiology 1/2023

Open Access 01-12-2023 | Postoperative Nausea and Vomiting | Study Protocol

Impact of gasless vNOTES vs. traditional vNOTES on hemodynamic profiles and outcomes in patients with benign gynecological disease: study protocol of a randomized controlled trial

Authors: Kai Liu, Qinghua Huang, Yanjun Wang, Qianqian Zhang, Dan Feng, Zhaolin Gong, Jiaojiao Chen, Li He, Yu Cui, Yonghong Lin

Published in: BMC Anesthesiology | Issue 1/2023

Login to get access

Abstract

Background

Literature regarding the advantages of gasless vNOTES is insufficient. The aim of our study is to compare gasless vNOTES vs. traditional vNOTES on hemodynamic profiles and outcomes in patients with benign gynecological disease. We hypothesize that compared with those in the traditional vNOTES group, hemodynamic profiles will be changed less during gasless vNOTES, while safety can be promised.

Methods

This is a single-center, prospective, single-blind, randomized controlled clinical trial, which has been approved by the Institutional Review Board of Chengdu Women’s and Children’s Hospital on September 27, 2022. One hundred and twenty patients will be recruited and randomly assigned to either the traditional vNOTES group or the gasless vNOTES group in a 1:1 ratio. For patients allocated to the traditional vNOTES group, after insertion of one port through the vagina, CO2 gas is infused with a pressure of 12–14 mmHg; while for those allocated to the gasless vNOTES group, a special device is used as an abdominal wall-lifting device to facilitate gasless surgery. CO2 pneumoperitoneum will not be used during the whole gasless vNOTES procedure. The primary outcome is vital signs at different time points. The secondary outcomes include surgical conversion rate, duration of surgery and anesthesia, anesthetic consumption, intraoperative estimated blood loss, VAS and PONV scores at postoperative 2 h and 24 h, administration of vasopressor drugs from the beginning of general anesthesia induction to 15 min after endotracheal intubation, including times, dosage, and type, intraoperative and postoperative complications, time of first getting out of bed after surgery, and time of first eating after surgery, including light drink.

Discussion

This is the first randomized controlled trial to compare the impacts of gasless vNOTES vs. traditional vNOTES on hemodynamic profiles and outcomes in patients with benign gynecological disease. If a favorable effect and safety of gasless vNOTES for hemodynamic profiles and outcomes in patients are shown, gasless vNOTES would be an optimal treatment option for patients with benign gynecological disease.

Trial registration

The trial was registered at https://​www.​chictr.​org.​cn/​showproj.​html?​proj=​182441 with registration No. ChiCTR2200064779 on Oct 17, 2022.
Appendix
Available only for authorised users
Literature
9.
go back to reference Chan AW, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:1–42.CrossRef Chan AW, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:1–42.CrossRef
10.
11.
go back to reference Minami T, Watanabe H, Kato T, Ikeda K, Ueno K, Matsuyama A, et al. Dexmedetomidine versus haloperidol for sedation of non-intubated patients with hyperactive delirium during the night in a high dependency unit: study protocol for an open-label, parallel-group, randomized controlled trial (DEX-HD trial). BMC Anesthesiol. 2023;23(1):193. https://doi.org/10.1186/s12871-023-02158-1. (Published 2023 Jun 3).CrossRefPubMedPubMedCentral Minami T, Watanabe H, Kato T, Ikeda K, Ueno K, Matsuyama A, et al. Dexmedetomidine versus haloperidol for sedation of non-intubated patients with hyperactive delirium during the night in a high dependency unit: study protocol for an open-label, parallel-group, randomized controlled trial (DEX-HD trial). BMC Anesthesiol. 2023;23(1):193. https://​doi.​org/​10.​1186/​s12871-023-02158-1. (Published 2023 Jun 3).CrossRefPubMedPubMedCentral
Metadata
Title
Impact of gasless vNOTES vs. traditional vNOTES on hemodynamic profiles and outcomes in patients with benign gynecological disease: study protocol of a randomized controlled trial
Authors
Kai Liu
Qinghua Huang
Yanjun Wang
Qianqian Zhang
Dan Feng
Zhaolin Gong
Jiaojiao Chen
Li He
Yu Cui
Yonghong Lin
Publication date
01-12-2023
Publisher
BioMed Central
Published in
BMC Anesthesiology / Issue 1/2023
Electronic ISSN: 1471-2253
DOI
https://doi.org/10.1186/s12871-023-02322-7

Other articles of this Issue 1/2023

BMC Anesthesiology 1/2023 Go to the issue