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Short-term Results of a Randomized Controlled Trial Comparing Primary Suture With Primary Glued Mesh Augmentation to Prevent Incisional Hernia

Timmermans, Lucas MD*; Eker, Hasan H. MD*,†,‡; Steyerberg, Ewout W. PhD; Jairam, An MD*; de Jong, Diederik MD, PhD§; Pierik, E. G. J. M. MD, PhD; Lases, S. S. MD; van der Ham, Arie C. MD, PhD; Dawson, Imro MD, PhD**; Charbon, Jan MD††; Schuhmacher, Christoph MD, PhD‡‡; Izbicki, Jakob R. MD, PhD§§; Neuhaus, Peter MD, PhD¶¶; Knebel, Peter MD, PhD‖‖; Fortelny, Rene MD, PhD***; Kleinrensink, Gert-Jan PhD†††; Jeekel, Johannes MD, PhD†††; Lange, Johan F. MD, PhD*

doi: 10.1097/SLA.0000000000000798
Randomized Controlled Trials

Background: Incisional hernia is one of the most frequent postoperative complications after abdominal surgery. Patients with an abdominal aortic aneurysm and patients with a body mass index of 27 or higher have an increased risk to develop incisional hernia. Primary mesh augmentation is a method in which the abdominal wall is strengthened to reduce incisional hernia incidence. This study focused on the short-term results of the PRImary Mesh Closure of Abdominal Midline Wounds trial, a multicenter double blind randomized controlled trial.

Methods: Between 2009 and 2012 patients were included if they were operated via midline laparotomy, and had an abdominal aortic aneurysm or a body mass index of 27 or higher. Patients were randomly assigned to either receive primary suture, onlay mesh augmentation (OMA), or sublay mesh augmentation.

Results: Outcomes represent results after 1-month follow-up. A total of 480 patients were randomized. During analysis, significantly (P = 0.002) more seromas were detected after OMA (n = 34, 18.1%) compared with primary suture (n = 5, 4.7%) and sublay mesh augmentation (n = 13, 7%). No differences were discovered in any of the other outcomes such as surgical site infection, hematoma, reintervention, or readmission. Multivariable analysis revealed an increase in seroma formation after OMA with an odds ratio of 4.3 (P = 0.004) compared with primary suture and an odds ratio of 2.9 (P = 0.003) compared with sublay mesh augmentation.

Conclusions: On the basis of these short-term results, primary mesh augmentation can be considered a safe procedure with only an increase in seroma formation after OMA, but without an increased risk of surgical site infection.

The PRImary Mesh Closure of Abdominal Midline Wounds trial is a multicenter randomized trial that compared 3 different closure techniques: onlay mesh augmentation, sublay mesh augmentation, and primary suture. The primary outcome of the study was incisional hernia prevention, however currently we present the short-term data that focus on infection, seroma, hematoma, and fascial dehiscence.

*Department of Surgery, Erasmus Medisch Centrum, Rotterdam, The Netherlands

Department of Surgery, Rode Kruis Ziekenhuis, Beverwijk, The Netherlands

Department of Biostatistics, Erasmus University Medisch Centrum, Rotterdam, The Netherlands

§Department of Gynaecology, Isala Hospital, Zwolle, The Netherlands

Department of Surgery, IsalaKlinieken, Zwolle, The Netherlands

Department of Surgery, SintFranciscusGasthuis, Rotterdam, The Netherlands

**Department of Surgery, IJsselland Ziekenhuis, Capelle aan de IJssel, The Netherlands

††Department of Surgery, Maxima Medisch Centrum, Veldhoven, The Netherlands

‡‡Department of Surgery, Technischen Universitat Munchen, Germany

§§Department of Surgery, University Hospital Hamburg Eppendorf, Germany

¶¶Department of Surgery, CHARITE-Universitatsmedizin, Berlin, Germany

‖‖Department of Surgery, University Clinic Heidelberg, Germany

***Department of Surgery, Wilhelminenspital, Vienna, Austria; and

†††Department of Neuroscience, Erasmus Medisch Centrum, Rotterdam, The Netherlands.

Reprints: Lucas Timmermans, MD, Erasmus MC, Department of Surgery, University Medical Center, Rotterdam, Z-835, 3000 CA Rotterdam, The Netherlands. E-mail:

Disclosure: Supported by B. Braun Surgical Spain, Rubi, Spain, and Baxter Healthcare, Deerfield, IL. Support was granted after the sponsors read the protocol before the initiation of the study. No other external sponsors were involved in this study. None of the sponsors were involved in the design, conduct or analysis of the study.

The authors declare that they have no other competing interests.

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