Safety and effectiveness of using Disposable Ultrasonic shears to coagulate 5-7 mm blood vessels: protocol for a prospective, multicenter, randomized, parallel controlled, non-inferiority clinical trial.

IF 1.6 3区医学 Q2 SURGERY

BMC Surgery Pub Date : 2024-07-19 DOI:10.1186/s12893-024-02497-x

Xipeng Wang, Chengqiang Li, Junqiang Fan, Jian Hu, Mingsong Wang, Hecheng Li

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Abstract

Background: The ultrasonic scalpel is widely used during surgery. It is safe and effective to close the pulmonary artery branch vessels of 7 mm or below with an ultrasonic energy device as reported. However, there have been no multicenter randomized clinical trial to assess the safety and effectiveness of using ultrasonic scalpel to coagulate 5-7 mm blood vessels in thoracic surgery.

Methods: This is a prospective, multicenter, randomized, parallel controlled, non-inferiority clinical trial. A total of 144 eligible patients planning to undergo lung or esophageal surgery will be randomly allocated to the experimental group and the control group. The investigational product (Disposable Ultrasonic Shears manufactured by Reach Surgical, Inc.) and the control product (Harmonic Ace + 7, 5 mm Diameter Shears with Advanced Hemostasis) will be used in each group. The primary endpoint is the success rate of coagulating target blood vessels during surgery. Secondary endpoints include postoperative rebleeding, intraoperative bleeding volume, drainage volume, surgical duration, etc. Postoperative follow-up before and after discharge will be performed.

Discussion: This clinical trial aims to evaluate the safety and effectiveness of using the investigational product (Disposable Ultrasonic Shears manufactured by Reach Surgical, Inc.) and that of the control product (Harmonic Ace + 7, 5 mm Diameter Shears with Advanced Hemostasis) to coagulate 5-7 mm blood vessels in thoracic surgery.

Trial registration: ClinicalTrials.gov: NCT06002737. The trial was prospectively registered on 16 August 2023, https://www.

Clinicaltrials: gov/study/NCT06002737 .

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使用一次性超声波剪凝固 5-7 毫米血管的安全性和有效性：前瞻性、多中心、随机、平行对照、非劣效性临床试验方案。

背景：超声刀在外科手术中被广泛使用。据报道，使用超声波能量装置关闭 7 毫米或以下的肺动脉分支血管是安全有效的。然而，目前还没有多中心随机临床试验来评估在胸外科手术中使用超声刀凝固 5-7 毫米血管的安全性和有效性：这是一项前瞻性、多中心、随机、平行对照、非劣效性临床试验。共有 144 名符合条件的计划接受肺部或食管手术的患者将被随机分配到实验组和对照组。每组都将使用研究产品（Reach Surgical 公司生产的一次性超声波剪）和对照产品（Harmonic Ace + 7，直径 5 毫米高级止血剪）。主要终点是手术中凝固靶血管的成功率。次要终点包括术后再出血、术中出血量、引流量、手术时间等。出院前后将进行术后随访：本临床试验旨在评估在胸外科手术中使用研究产品（Reach Surgical 公司生产的一次性超声波剪）和对照产品（Harmonic Ace + 7，直径 5 毫米高级止血剪）凝固 5-7 毫米血管的安全性和有效性：试验注册：ClinicalTrials.gov：试验注册：ClinicalTrials.gov：NCT06002737。该试验于 2023 年 8 月 16 日进行了前瞻性注册，https://www.Clinicaltrials：gov/study/NCT06002737 。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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