开展一项开放性前瞻性观察性多中心队列研究，以确定腹腔镜腹膜内补片修补术（IPOM）标准化治疗切口疝对临床结局和生活质量的影响（LIPOM试验）。
Development of an open prospective observational multicentre cohort study to determine the impact of standardization of laparoscopic intraperitoneal onlay mesh repair (IPOM) for incisional hernia on clinical outcome and quality of life (LIPOM-Trial).
作者信息
Hellinger A, Wotzlaw F, Fackeldey V, Pistorius G, Zdichavsky M, Jünemann R, Buia A
机构信息
Department of General and Visceral Surgery, Klinikum Fulda, Universitätsmedizin Marburg - Campus Fulda, Fulda, Germany.
Department of General, Vascular and Visceral Surgery, Klinik Kitzinger Land, Kitzingen, Germany.
出版信息
Contemp Clin Trials Commun. 2016 Aug 11;4:118-123. doi: 10.1016/j.conctc.2016.08.001. eCollection 2016 Dec 15.
BACKGROUND
Incisional hernias are one of the most frequent complications in abdominal surgery. Laparoscopic repair has been widely used since its first description but has not been standardized. A panel of hernia experts with expertise on the subject "incisional hernia" was established to review existing literature and define a standard approach to laparoscopic IPOM-repair for incisional hernia. All involved surgeons agreed to perform further IPOM-repairs of incisional hernia according to the protocol.
METHODS/DESIGN: This article summarizes the development of an open prospective observational multicentre cohort study to analyse the impact of a standardization of laparoscopic IPOM-repair for incisional hernia on clinical outcome and quality of life (health care research study).
DISCUSSION
Our literature search found that there is a lack of standardization in the surgical approach to incisional hernia and the use of medical devices. The possibility of different surgical techniques, various meshes and a variety of mesh fixation techniques means that the results on outcome after incisional hernia repair are often not comparable between different studies. We believe there is a need for standardization of the surgical procedure and the use of medical devices in order to make the results more comparable and eliminate confounding factors in interpreting the results of surgical hernia repair. This approach, in our view, will also illustrate the influence of the operative technique on the general quality of surgical treatment of incisional hernias better than a "highly selective" study and will indicate the "reality" of surgical treatment not only in specialist centres.
TRIAL REGISTRATION
The LIPOM-trial is registered at www.clinicaltrials.gov, with identifier: NCT02089958.
背景
切口疝是腹部手术中最常见的并发症之一。自首次描述以来，腹腔镜修补术已被广泛应用，但尚未标准化。成立了一个由切口疝领域专家组成的小组，以回顾现有文献并确定切口疝腹腔镜腹腔内补片修补术（IPOM）的标准方法。所有参与的外科医生都同意根据该方案进一步进行切口疝的IPOM修补术。
方法/设计：本文总结了一项开放性前瞻性观察性多中心队列研究的开展情况，以分析切口疝腹腔镜IPOM修补术标准化对临床结局和生活质量的影响（卫生保健研究）。
讨论
我们的文献检索发现，切口疝的手术方法和医疗器械的使用缺乏标准化。不同的手术技术、各种补片和多种补片固定技术的可能性意味着，不同研究之间切口疝修补术后的结果往往不可比。我们认为，需要对外科手术程序和医疗器械的使用进行标准化，以使结果更具可比性，并消除解释疝修补手术结果时的混杂因素。我们认为，这种方法也将比“高度选择性”研究更好地说明手术技术对切口疝外科治疗总体质量的影响，并不仅在专科中心显示外科治疗的“实际情况”。
试验注册
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