Watchful waiting vs surgical repair of oligosymptomatic incisional hernias: Current status of the AWARE study

Abstract

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.