A new minimally invasive, nonexcisional, surgical browlift technique with minimal scarring: a protocol for a prospective observational study

Frank W. de Jongh, Laurens Kooiman, Elijah E. Sanches, S. Pouwels, Koen J A O Ingels, K. Wehrens, Liang T. Tan
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Abstract

The aim of this study is to prospectively evaluate the new minimal invasive (MINE) browlift technique with possibly superior results and minimal visible scarring. A prospective observational study will be performed on all available data from patients who will undergo a browlift procedure in the HMC from 1 June 2021 till 31 May 2024. Our goal is to include at least 50 patients. Inclusion criteria are: patients with medical (i.e. brow ptosis and facial paralysis) or cosmetic indication, patients with sufficient understanding of the Dutch or English language and willingness to participate in extra study specific follow-up moments and filling in of questionnaires. Exclusion criteria are: less than 18 years of age and patients with previous brow or eyelid surgery. Patients will be photographed preoperatively and postoperatively using the VECTRA camera. Scarring after procedure; functionality of eyebrow movement; amount of correction in brow ptosis, measured in VECTRA; longevity of procedure in months; aesthetic result as assessed by questionnaires and adverse effects of procedure will be measured. The database management software ʻCastorʼ will be used to store and collect the data from the questionnaire. The Medical Research Ethics Committee found this study not eligible to be submitted to the Dutch Medical Research Involving Human Subjects Acts (WMO). Written consent will be obtained from all patients.
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疤痕最小的新型微创、非切除、外科提眉术:前瞻性观察研究方案
这项研究的目的是前瞻性地评估新的微创(MINE)提眉术,该技术可能具有更好的效果,而且疤痕不明显。 我们将对 2021 年 6 月 1 日至 2024 年 5 月 31 日期间在哈医大一院接受提眉术的患者的所有可用数据进行前瞻性观察研究。我们的目标是纳入至少 50 名患者。纳入标准是:有医学指征(即眉下垂和面瘫)或美容指征的患者,充分理解荷兰语或英语的患者,愿意参加额外的研究特定随访时间并填写调查问卷的患者。排除标准为:年龄小于 18 岁,曾接受过眉毛或眼睑手术的患者。将使用 VECTRA 相机为患者拍摄术前和术后照片。 将测量术后瘢痕、眉毛活动功能、VECTRA 测量的眉下垂矫正量、以月为单位的手术寿命、通过问卷评估的美学效果以及手术的不良反应。 将使用数据库管理软件ʻCastorʼ来存储和收集问卷调查的数据。医学研究伦理委员会认为,这项研究不符合荷兰《涉及人类研究对象的医学研究法》(WMO)的要求。所有患者都将获得书面同意。
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期刊介绍: IJS Protocols is the first peer-reviewed, international, open access journal seeking to publish research protocols across across the full breadth of the surgical field. We are aim to provide rapid submission to decision times whilst maintaining a high quality peer-review process.
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