背景:腔内激光消融(EVLA)在大隐静脉(GSV)功能不全的治疗中具有良好的效果。然而,热消融的使用需要肿胀麻醉,并且存在热损伤的风险.机械化学腔内消融(MOCA)是一种非热消融(NTA)替代方法,将机械内皮损伤与硬化剂液体或泡沫的输注相结合。不需要肿胀麻醉。与EVLA相比,MOCA使用Clariven装置的初步经验表明,术中和术后疼痛较少,临床改善较快。弗列博格里夫(鲍顿,波兰)是一种相对较新的MOCA设备。要使用Flebogrif确定MOCA的作用,一个精心设计的,需要足够样本量和随访时间的随机对照临床试验.在这篇文章中,我们提供了REBORN试验的研究方案,旨在证明使用Flebogrif的MOCA在治疗GSV功能不全的解剖学成功方面并不逊色于EVLA。
方法:这个多中心,开放标签,非自卑,观察者失明,随机对照试验在Flebogrif和EVLA之间随机分配被诊断为GSV功能不全,年龄为18~80岁的患者.3个参与中心的310名患者(西北诊所阿尔克马尔,皮肤和静脉诊所OosterwalAlkmaar和红十字会医院Beverwijk)将包括在内。主要结果是12个月时的解剖学成功。次要结果是术中疼痛,操作时间,技术上的成功,术后疼痛,安全,在其他随访时刻的解剖学成功,并发症,临床成功,美学结果,疾病特异性生活质量,再干预,前副隐静脉反流和新生血管形成。患者将在1周随访,治疗后1、6、12、24和60个月。
背景:机构审查委员会(Vrije大学医学中心的医学伦理审查委员会)于2021年5月17日批准了该研究,病例号为2020.0740。书面知情同意书由协调研究者在研究登记之前从所有参与者获得。审判结束后,研究结果将提交给国际科学杂志进行同行评审。
背景:荷兰的OverzichtvanMedisch-wetenschappelijkOnderzoek,NL-OMON25145,以前为NL9527;中央委员会MensgebondenOnderzoek,NL74491.029.20。
BACKGROUND: Endovenous laser ablation (EVLA) is associated with an excellent outcome in the treatment of great saphenous vein (GSV) incompetence. However, the use of thermal ablation requires tumescent anaesthesia and is associated with a risk of thermal damage. Mechanochemical endovenous ablation (MOCA) is a non-thermal ablation (NTA) alternative, which combines mechanical endothelial damage with the infusion of a sclerosant liquid or foam. Tumescent anaesthesia is not required. Preliminary experiences with MOCA using the Clarivein device show less intraprocedural and postprocedural pain and a faster clinical improvement compared with EVLA. Flebogrif (Balton, Poland) is a relatively new MOCA device. To determine the role of MOCA using Flebogrif, a well-designed, randomised controlled clinical trial of sufficient sample size and follow-up time is required. In this article, we provide the study protocol for the REBORN trial, aiming to demonstrate that MOCA using Flebogrif is not inferior to EVLA for the outcome of anatomical success in the treatment of GSV incompetence.
METHODS: This multicentre, open-label, non-inferiority, observer-blinded, randomised controlled trial randomises patients who are diagnosed with GSV incompetence and aged 18-80 years between Flebogrif and EVLA. 310 patients in 3 participating centres (Northwest Clinics Alkmaar, Skin and Vein Clinic Oosterwal Alkmaar and Red Cross Hospital Beverwijk) will be included. The primary outcome is anatomical success at 12 months. Secondary outcomes are intraprocedural pain, operation time, technical success, postprocedural pain, safety, anatomical success during other follow-up moments, complications, clinical success, aesthetic result, disease-specific quality of life, reinterventions, anterior accessory saphenous vein reflux and neovascularisation. Patients will be followed up at 1 week, 1, 6, 12, 24 and 60 month(s) after treatment.
BACKGROUND: The institutional review board (Medical Ethical Review Committee of the Vrije Universiteit Medical Center) approved this study on 17 May 2021 under case number 2020.0740. Written informed consent is obtained by the coordinating investigator from all participants prior to study enrolment. After completion of the trial, the results will be submitted to an international scientific journal for peer-reviewed publication.
BACKGROUND: Overzicht van Medisch-wetenschappelijk Onderzoek in Nederland, NL-OMON25145, previously NL9527; Centrale Commissie Mensgebonden Onderzoek, NL74491.029.20.