Poelman Marijn, Apers Jan, van den Brand Han, Cense Huib, Consten Esther, Deelder Jort, Dwars Boudewijn, van Geloven Nanette, de Lange Elly, Lange Johan, Simmermacher Rogier, Simons Maarten, Sonneveld Eric, Schreurs Hermien, Bonjer Jaap
VU University Medical Centre, Amsterdam, Netherlands.
BMC Surg. 2013 Jun 7;13:18. doi: 10.1186/1471-2482-13-18.
Annually approximately 100.000 patients undergo a laparotomy in the Netherlands. About 15,000 of these patients will develop an incisional hernia. Both open and laparoscopic surgical repair have been proven to be safe. However, the most effective treatment of incisional hernias remains unclear. This study, the 'INCH-trial', comparing cost-effectiveness of open and laparoscopic incisional hernia repair, is therefore needed.
METHODS/DESIGN: A randomized multi-center clinical trial comparing cost-effectiveness of open and laparoscopic repair of incisional hernias. Patients with a symptomatic incisional hernia, eligible for laparoscopic and open incisional hernia repair. Only surgeons, experienced in both open and laparoscopic incisional hernia repair, will participate in the INCH trial. During incisional hernia repair, a mesh is placed under or on top of the fascia, with a minimal overlap of 5 cm. Primary endpoint is length of hospital stay after an incisional hernia repair. Secondary endpoints are time to full recovery within three months after index surgery, post-operative complications, recurrences, mortality and quality of life.Our hypothesis is that laparoscopic incisional hernia repair comes with a significant shorter hospital stay compared to open incisional hernia repair. A difference of two days is considered significant. One-hunderd-and-thirty-five patients are enrolled in each treatment arm. The economic evaluation will be performed from a societal perspective. Primary outcomes are costs per patient related to time-to-recovery and quality of life.The main goal of the trial is to establish whether laparoscopic incisional hernia repair is superior to conventional open incisional hernia repair in terms of cost-effectiveness. This is measured through length of hospital stay and quality of life. Secondary endpoints are re-operation rate due to post-operative complications or recurrences, mortality and quality of life.
The difference in time to full recovery between the two treatment strategies is thought to be in favor of laparoscopic incisional hernia repair. Laparoscopic incisional hernia repair is therefore expected to be a more cost-effective approach.
Netherlands Trial register: NTR2808.
在荷兰，每年约有100000名患者接受剖腹手术。其中约15000名患者会发生切口疝。开放手术和腹腔镜手术修复均已被证明是安全的。然而，切口疝最有效的治疗方法仍不明确。因此，需要进行这项“INCH试验”，比较开放和腹腔镜切口疝修补术的成本效益。
方法/设计：一项随机多中心临床试验，比较开放和腹腔镜切口疝修补术的成本效益。有症状的切口疝患者，适合腹腔镜和开放切口疝修补术。只有同时具备开放和腹腔镜切口疝修补经验的外科医生才会参与INCH试验。在切口疝修补过程中，将补片放置在筋膜下方或上方，最小重叠5厘米。主要终点是切口疝修补术后的住院时间。次要终点是首次手术后三个月内完全康复的时间、术后并发症、复发、死亡率和生活质量。我们的假设是，与开放切口疝修补术相比，腹腔镜切口疝修补术的住院时间显著缩短。两天的差异被认为具有显著性。每个治疗组招募135名患者。经济评估将从社会角度进行。主要结果是每位患者与康复时间和生活质量相关的成本。该试验的主要目的是确定腹腔镜切口疝修补术在成本效益方面是否优于传统的开放切口疝修补术。这通过住院时间和生活质量来衡量。次要终点是因术后并发症或复发导致的再次手术率、死亡率和生活质量。
两种治疗策略在完全康复时间上的差异被认为有利于腹腔镜切口疝修补术。因此，腹腔镜切口疝修补术预计是一种更具成本效益的方法。
荷兰试验注册：NTR2808。
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