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Randomized Controlled Trial Multicenter Study
Prevention of Incisional Hernias by Prophylactic Mesh-augmented Reinforcement of Midline Laparotomies for Abdominal Aortic Aneurysm Treatment: A Randomized Controlled Trial.
- Filip E Muysoms, Olivier Detry, Tijl Vierendeels, Marc Huyghe, Marc Miserez, Martin Ruppert, Tim Tollens, Jean-Olivier Defraigne, and Frederik Berrevoet.
- *Department of Surgery, AZ Maria Middelares Hospital, Ghent, Belgium†Department of Surgery, CHU Liege, University de Liege, Liege, Belgium‡Department of Surgery, ASZ Hospital, Aalst, Belgium§Department of Surgery, Sint Augustinus Hospital, Antwerpen, Belgium¶Department of Abdominal Surgery, University Hospital Gasthuisberg, Leuven, Belgium||Department of Surgery, University Hospital Antwerpen, Edegem, Belgium**Department of Surgery, Imelda Hospital Bonheiden, Bonheiden, Belgium††Department of Vascular Surgery, CHU Liege, University de Liege, Liege, Belgium‡‡Department of General and Hepatobiliary Surgery, Ghent University Hospital, Ghent, Belgium.
- Ann. Surg. 2016 Apr 1; 263 (4): 638-45.
BackgroundThe incidence of incisional hernias after abdominal aortic aneurysm repair is high. Prophylactic mesh-augmented reinforcement during laparotomy closure has been proposed in patients at high risk of incisional hernia.MethodsA multicenter randomized trial was conducted on patients undergoing elective abdominal aortic aneurysm repair through a midline laparotomy (Clinical.Trials.gov: NCT00757133). In the study group, retromuscular mesh-augmented reinforcement was performed with a large-pore polypropylene mesh (Ultrapro, width 7.5 cm). The primary endpoint was the incidence of incisional hernias at 2-year follow-up.ResultsBetween February 2009 and January 2013, 120 patients were recruited at 8 Belgian centers. Patients' characteristics at baseline were similar between groups. Operative and postoperative characteristics showed no difference in morbidity or mortality. The cumulative incidence of incisional hernias at 2-year follow-up after conventional closure was 28% (95% confidence interval [CI], 17%-41%) versus 0% (95% CI, 0%-6%) after mesh-augmented reinforcement (P < 0.0001; Fisher exact test). The estimated "freedom of incisional hernia" curves (Kaplan-Meier estimate) were significantly different across study arms (χ = 19.5, P < 0.0001; Mantel-Cox test). No adverse effect related to mesh-augmented reinforcement was observed, apart from an increased mean time to close the abdominal wall for mesh-augmented reinforcement compared with the control group: 46 minutes (SD, 18.6) versus 30 minutes (SD, 18.5), respectively (P < 0.001; Mann-Whitney U test).ConclusionsProphylactic retromuscular mesh-augmented reinforcement of a midline laparotomy in patients with abdominal aortic aneurysm is safe and effectively prevents the development of incisional hernia during 2 years, with an additional mean operative time of 16 minutes.
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