Department of General, Vascular, and Thoracic Surgery, Charité Campus Benjamin Franklin, Hindenburgdamm 30, 12200 Berlin, Germany.
Trials. 2012 Feb 7;13:14. doi: 10.1186/1745-6215-13-14.
Incisional hernia is a frequent complication in abdominal surgery. This article describes the development of a prospective randomized clinical trial designed to determine whether watchful waiting is an acceptable alternative to surgical repair for patients with oligosymptomatic incisional hernia.
METHODS/DESIGN: This clinical multicenter trial has been designed to compare watchful waiting and surgical repair for patients with oligosymptomatic incisional hernia. Participants are randomized to watchful waiting or surgery and followed up for two years. The primary efficacy endpoint is pain/discomfort during normal activities as a result of the hernia or hernia repair two years after enrolment, as measured by the hernia-specific Surgical Pain Scales (SPS). The target sample size of six hundred thirty-six patients was calculated to detect non-inferiority of the experimental intervention (watchful waiting) in the primary endpoint. Sixteen surgical centers will take part in the study and have submitted their declaration of commitment giving the estimated number of participating patients per year. A three-person data safety monitoring board will meet annually to monitor and supervise the trial.
To date, we could find no published data on the natural course of incisional hernias. To our knowledge, watchful waiting has never been compared to standard surgical repair as a treatment option for incisional hernias. A trial to compare the outcome of the two approaches in patients with oligosymptomatic incisional hernias is urgently needed to provide data that can facilitate the choice between treatment options. If watchful waiting was equal to surgical repair, the high costs of surgical repair could be saved. The design for such a trial is described here. This multicenter trial will be funded by the German Research Foundation (DFG). The ethics committee of the Charité has approved the study protocol. Approval has been obtained from ten study sites at time of this submission. The electronic Case Report Forms have been created. The first patient was to be randomized November 14th, 2011. An initiation meeting took place in Berlin January 9th, 2012.
ClinicalTrials.gov: NCT01349400.
切口疝是腹部手术后的常见并发症。本文描述了一项前瞻性随机临床试验的开展情况，旨在确定对于症状轻微的切口疝患者，静观等待是否是手术修补的一种可接受的替代方法。
方法/设计：这项多中心临床试验旨在比较静观等待和手术修补治疗症状轻微的切口疝患者。将参与者随机分为静观等待组或手术组，并随访两年。主要疗效终点是入组后两年由于疝或疝修补导致的正常活动时的疼痛/不适，采用特定于疝的手术疼痛量表（SPS）进行测量。根据主要终点，计算出需要 636 例患者的目标样本量，以检测实验组（静观等待）的非劣效性。16 个外科中心参与了这项研究，并提交了参与患者的估计数量。一个三人数据安全监测委员会将每年开会，以监测和监督试验。
迄今为止，我们没有发现关于切口疝自然病程的已发表数据。据我们所知，静观等待从未被作为切口疝的治疗选择与标准手术修复进行比较。迫切需要一项比较这两种方法在症状轻微的切口疝患者中的结果的试验，以提供可以促进治疗选择的相关数据。如果静观等待与手术修复相当，就可以节省手术修复的高昂费用。这里描述了这种试验的设计。这项多中心试验由德国研究基金会（DFG）资助。Charité 的伦理委员会已经批准了研究方案。在提交时，已经有十个研究点获得了批准。电子病例报告表已经创建。第一位患者于 2011 年 11 月 14 日进行随机分组。2012 年 1 月 9 日在柏林举行了启动会议。
ClinicalTrials.gov：NCT01349400。
