title: Effect of suture technique on the occurrence of incisional hernia after elective midline abdominal wall closure: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Based on a recent meta-analysis, a continuous suture technique with a suture to wound length ratio of at least 4:1, using a slowly absorbable monofilament suture material, is recommended for primary median laparotomy closure. Incisional hernia, which develops in 9 to 20% of patients, remains the major complication of abdominal wall closure. Current clinical data indicate that the incidence of incisional hernias increases by 60% between the first and the third year after median laparotomy, implicating that a follow-up period of 1 year postoperatively is too short with regard to this common complication. Trauma to the abdominal wall can be reduced by improvements in suture technique as well as suture material. Several factors, such as stitch length, suture tension, elasticity, and tensile strength of the suture material are discussed and currently under investigation. A Swedish randomized controlled trial showed a significant reduction in the incisional hernia rate by shortening the stitch length. However, a non-elastic thread was used and follow-up ended after 12 months. Therefore, we designed a multicenter, international, double-blinded, randomized trial to analyze the influence of stitch length, using an elastic, extra-long term absorbable monofilament suture, on the long term clinical outcome of abdominal wall closure.
  
  
  METHODS
  In total, 468 patients undergoing an elective, median laparotomy will be randomly allocated to either the short stitch or the long stitch suture technique for abdominal wall closure in a 1:1 ratio. Centers located in Germany and Austria will participate. The primary endpoint measure is the incisional hernia rate 1 year postoperatively, as verified by ultrasound. The frequency of short term and long term complications as well as costs, length of hospital stay and patients' quality of life (EQ-5D-5 L) will be considered as secondary parameters. Following hospital discharge, patients will be examined after 30 days and 1, 3, and 5 years after surgery.
  
  
  CONCLUSIONS
  This study will provide further evidence on whether a short stitch suture technique in combination with an elastic, extra-long term absorbable monofilament suture can prevent incisional hernias in the long term, compared with the long stitch suture technique.
  
  
  BACKGROUND
  NCT01965249 .
authors.affiliation: Department of Surgery, Wilhelminenspital, Montleartstrasse 37, 1160, Vienna, Austria. rene.fortelny@wienkav.at.
authors.forename: René H
authors.initials: RH
authors.lastname: Fortelny
authors.affiliation: Department of Medical Scientific Affairs, Aesculap AG, Am Aesculap Platz, 78532, Tuttlingen, Germany. petra.baumann@aesculap.de.
authors.forename: Petra
authors.initials: P
authors.lastname: Baumann
authors.affiliation: Department of General, Visceral, Transplantation, Vascular and Thoracic Surgery, Grosshadern Hospital, Ludwig Maximilian University, Marchioninistrasse 15, 81377, Munich, Germany. wolfgang.thasler@med.uni-muenchen.de.
authors.forename: Wolfgang E
authors.initials: WE
authors.lastname: Thasler
authors.affiliation: Department of General, Visceral, Transplantation, Vascular and Thoracic Surgery, Grosshadern Hospital, Ludwig Maximilian University, Marchioninistrasse 15, 81377, Munich, Germany. markus.albertsmeier@med.uni-muenchen.de.
authors.forename: Markus
authors.initials: M
authors.lastname: Albertsmeier
authors.affiliation: Department of Surgery, ALP FILS Kliniken, Eichertstrasse 3, 73035, Göppingen, Germany. stefan.riedl@af-k.de.
authors.forename: Stefan
authors.initials: S
authors.lastname: Riedl
authors.affiliation: Department of Surgery, Robert Bosch Krankenhaus, Auerbachstrasse 110, 70376, Stuttgart, Germany. wolfgang.steurer@rbk.de.
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Steurer
authors.affiliation: Department of Surgery, Klinikum Landkreis Tuttlingen, Zeppelinstrasse 21, 78532, Tuttlingen, Germany. j.kewer@klinikum-tut.de.
authors.forename: Jan Ludolf
authors.initials: JL
authors.lastname: Kewer
authors.affiliation: Department of Surgery, AKh Linz, Krankenhausstrasse 9, 4021, Linz, Austria. chirurgie2@akh.linz.at.
authors.forename: Andreas
authors.initials: A
authors.lastname: Shamiyeh
mesh_terms: D034861:Abdominal Wall / Q000601:surgery*; D002985:Clinical Protocols; D004311:Double-Blind Method; D017558:Elective Surgical Procedures; D006801:Humans; D000069290:Incisional Hernia / Q000453:epidemiology / Q000517:prevention & control*; D017063:Outcome Assessment, Health Care; D011786:Quality Control; D018401:Sample Size; D013536:Suture Techniques