title: Short-term results of a randomized controlled trial comparing primary suture with primary glued mesh augmentation to prevent incisional hernia.
abstract: 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.
authors.affiliation: *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.
authors.forename: Lucas
authors.initials: L
authors.lastname: Timmermans
authors.forename: Hasan H
authors.initials: HH
authors.lastname: Eker
authors.forename: Ewout W
authors.initials: EW
authors.lastname: Steyerberg
authors.forename: An
authors.initials: A
authors.lastname: Jairam
authors.forename: Diederik
authors.initials: D
authors.lastname: de Jong
authors.forename: E G J M
authors.initials: EG
authors.lastname: Pierik
authors.forename: S S
authors.initials: SS
authors.lastname: Lases
authors.forename: Arie C
authors.initials: AC
authors.lastname: van der Ham
authors.forename: Imro
authors.initials: I
authors.lastname: Dawson
authors.forename: Jan
authors.initials: J
authors.lastname: Charbon
authors.forename: Christoph
authors.initials: C
authors.lastname: Schuhmacher
authors.forename: Jakob R
authors.initials: JR
authors.lastname: Izbicki
authors.forename: Peter
authors.initials: P
authors.lastname: Neuhaus
authors.forename: Peter
authors.initials: P
authors.lastname: Knebel
authors.forename: Rene
authors.initials: R
authors.lastname: Fortelny
authors.forename: Gert-Jan
authors.initials: GJ
authors.lastname: Kleinrensink
authors.forename: Johannes
authors.initials: J
authors.lastname: Jeekel
authors.forename: Johan F
authors.initials: JF
authors.lastname: Lange
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006555:Hernia, Ventral / Q000209:etiology / Q000517:prevention & control*; D006801:Humans; D057194:Intention to Treat Analysis; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D016017:Odds Ratio; D011183:Postoperative Complications / Q000209:etiology / Q000517:prevention & control*; D012307:Risk Factors; D013526:Surgical Mesh; D013536:Suture Techniques; D014014:Tissue Adhesives; D016896:Treatment Outcome
chemical_list: D014014:Tissue Adhesives