Abdominal incision defect following AAA-surgery (AIDA): 2-year results of prophylactic onlay-mesh augmentation in a multicentre, double-blind, randomised controlled trial

Abstract

The reported incidence of incisional hernia following repair of abdominal aortic aneurysm (AAA) via midline laparotomy is up to 69%. This prospective, multicenter, double-blind, randomised controlled trial was conducted at eleven hospitals in Germany. Patients aged 18 years or older undergoing elective AAA-repair via midline incision were randomly assigned using a computer-generated randomisation sequence to one of three groups for fascial closure: with long-term absorbable suture (MonoPlus®, group I), long-term absorbable suture and onlay mesh reinforcement (group II) or extra long-term absorbable suture (MonoMax®, group III). The primary endpoint was the incidence of incisional hernia within 24 months of follow-up, analysed by intention to treat. Physicians conducting the postoperative visits and the patients were blinded. Between February 2011 and July 2013, 104 patients (69.8 ± 7.7 years) were randomised, 99 of them received a study intervention. The rate of incisional hernia within 24 months was not significantly reduced with onlay mesh augmentation compared to primary suture (p = 0.290). Furthermore, the rate of incisional hernia did not differ significantly between fascial closure with slow and extra long-term absorbable suture (p = 0.111). Serious adverse events related to study intervention occurred in five patients (5.1%) from treatment groups II and III. Wound healing disorders were more frequently seen after onlay mesh implantation on the day of discharge (p = 0.010) and three (p = 0.009) and six (p = 0.023) months postoperatively. The existing evidence on prophylactic mesh augmentation in patients undergoing AAA-repair via midline laparotomy probably needs critical review. As the implementation of new RCTs is considered difficult due to the increasing number of endovascular AAA treated, registry studies could help to collect and evaluate data in cases of open AAA-repair. Comparisons between prophylactic mesh implantation and the small bite technique are also required. Trial registration: ClinicalTrials.gov Identifier: NCT01353443. Funding Sources: Aesculap AG, Tuttlingen, Germany.

Prevention of Incisional Hernias by Prophylactic Mesh-augmented Reinforcement of Midline Laparotomies for Abdominal Aortic Aneurysm Treatment

“…published 13 . In this study, authors were not able to confirm a significant reduction in the rate of IHs with the use of PMR after open AAA repair, when compared to a suture closure using a 4:1 SL/WL with a slowly absorbable running suture.…”

“…Four of the published RCTs used a synthetic polypropylene mesh [9][10][11] , and one reported using a bovine pericardium mesh 12 . Both onlay and retrorectus mesh positions have been proposed and investigated, with no clear benefit shown for either of these approaches [9][10][11][12][13] . When an onlay mesh was used an increase in seroma formation was seen, although this did not lead to an increase in reinterventions, and generally did not pose a clinically relevant problem 10,12,13 .…”

“…Both onlay and retrorectus mesh positions have been proposed and investigated, with no clear benefit shown for either of these approaches [9][10][11][12][13] . When an onlay mesh was used an increase in seroma formation was seen, although this did not lead to an increase in reinterventions, and generally did not pose a clinically relevant problem 10,12,13 . However, in a recent publication reporting on infectious complications during a 2-year follow-up of the PRIMA trial, a greater number of infectious complications were seen in the group that had an onlay mesh position, when compared to a rectrorectus mesh position 18 .…”

“…One randomized trial, the AIDA-trial (abdominal incision defect following AAA-surgery), failed to demonstrate this benefit, and reported similar rates of IHs when comparing primary closure and the use of an onlay PMR 13,14 . However, inclusion numbers in this study were not met, and a significant lack of power limits the interpretation of these results.…”

“…Whether this is because these IHs do not pose a clinically relevant problem, or because surgeons are reluctant to operate on patients with significant comorbidities remains grossly unknown and underreported 1,[9][10][11][12][13]15 .…”