Lauscher J C, Leonhardt M, Martus P, Zur Hausen G, Aschenbrenner K, Zurbuchen U, Thielemann H, Kohlert T, Schirren R, Simon T, Buhr H J, Ritz J-P, Kreis M E
Klinik für Allgemein-, Viszeral- und Gefäßchirurgie, Charité Campus Benjamin Franklin, Hindenburgdamm 30, 12203, Berlin, Deutschland.
Institut für Klinische Epidemiologie und angewandte Biometrie, Universitätsklinikum Tübingen, Silcherstr. 5, 72076, Tübingen, Deutschland.
Chirurg. 2016 Jan;87(1):47-55. doi: 10.1007/s00104-015-0011-2.
Incisional hernias are one of the the most frequent complications in visceral surgery and incisional hernia repair has a relevant complication rate. Therefore, there have to be solid indications before carrying out incisional hernia repair. To date, there is a lack of evidence concerning the correct indications for surgical repair of incisional hernias. The AWARE trial compares watchful waiting to surgical repair of incisional hernias.
The AWARE trial is a prospective randomized multicenter trial. Patients with asymptomatic or oligosymptomatic incisional hernia are randomized into the watchful waiting or the surgical repair group with a follow-up of 2 years. The primary endpoint is pain during normal activities due to the hernia or the hernia repair after 2 years measured on the hernia-specific surgical pain scale (SPS).
In this study 36 centers are participating throughout Germany, more than 1600 patients had been screened up to 31 December 2014 and 234 (14.6%) of the screened patients could be recruited.
The AWARE study will provide evidence concerning the two therapeutic options of watchful waiting and surgical repair of incisional hernia.
切口疝是内脏外科最常见的并发症之一，切口疝修补术的并发症发生率较高。因此，在进行切口疝修补术前必须有确凿的指征。迄今为止，关于切口疝手术修补的正确指征缺乏证据。AWARE试验比较了对切口疝进行观察等待与手术修补的效果。
AWARE试验是一项前瞻性随机多中心试验。将无症状或症状轻微的切口疝患者随机分为观察等待组或手术修补组，随访2年。主要终点是2年后根据疝特异性手术疼痛量表（SPS）测量的因疝或疝修补导致的正常活动时的疼痛。
在本研究中，德国各地有36个中心参与，截至2014年12月31日，已筛查了1600多名患者，其中234名（14.6%）被招募。
AWARE研究将为切口疝观察等待和手术修补这两种治疗选择提供证据。
