Marc Miserez1, Rolf Lefering2, Federico Famiglietti1, Tim Mathes2, Dörthe Seidel2, Stefan Sauerland2, Dragan Korolija3, Markus Heiss4, Gyorgy Weber5, Ferdinando Agresta6, Willem-Hans Steup7, Maciej Śmietański8, Rui Ribeiro9, Diego Cuccurullo10, Fausto Catena11, Claudia Rudroff12, Georg Rosanelli13, Fabian Schön14, Bart Smet15, Frank Wenger16, Stefano Saad17, Lars Naver18, Edmund Neugebauer2,19. 1. Department of Abdominal Surgery, University Hospital Gasthuisberg, KU Leuven, Leuven, Belgium. 2. Institut für Forschung in der Operativen Medizin (IFOM), Witten/Herdecke University, Cologne, Germany. 3. Day-care Surgery Department at Cancer Centre, University Hospital Sestre Milosrdnice, Zagreb, Croatia. 4. Department for Visceral Surgery, Vascular Surgery and Transplantation, Cologne Merheim Medical Center, Cologne, Germany. 5. Department of Surgical Research and Techniques, Semmelweis University, Budapest, Hungary. 6. Department of General Surgery, ULSS5 Polesana del Veneto, Adria, (RO), Italy. 7. Department of Surgery, Haga Hospital, The Hague, The Netherlands. 8. 2nd Department of Radiology, Medical University of Gdańsk, Gdańsk, Poland. 9. Clínica de Santo António - Lusíadas, Amadora, Portugal. 10. General Laparoscopic and Robotic Surgery, AORN dei Colli Monaldi Hospital, Naples, Italy. 11. Emergency Surgery Department, Parma University Hospital, Parma, Italy. 12. Department of General and Visceral Surgery, Evangelisches Klinikum Koeln Weyertal, Cologne, Germany. 13. Department of Surgery, University Doz. Krankenhaus der Elisabethinen GmbH, Graz, Austria. 14. Leitender Oberarzt Facharzt für Chirurgie und Viszeralchirurgie Chirurgische Klinik, Offenbach am Main, Germany. 15. General and Abdominal Surgery, AZ Delta Campus Wilgenstraat, Roeselare, Belgium. 16. Clinic of General, Visceral and Thoracic Surgery, Asklepios Südpfalzklinik Kandel, Kandel, Germany. 17. Department of General Surgery, Clinic Gummersbach, Academic Hospital, University of Cologne, Gummersbach, Germany. 18. Department of Surgical Gastroenterology, University Hospital Hvidovre, Hvidovre, Denmark. 19. Brandenburg Medical School Theodor Fontane, Neuruppin, Germany.
Abstract
OBJECTIVE: The aim of this study was to investigate the approach (open or laparoscopic) and mesh type (synthetic or biological) in ventral hernias in a clean setting.Summary of Background Data: The level of evidence on the optimal surgical approach and type of mesh in ventral hernia repair is still low. METHODS: Patients with a ventral abdominal hernia (diameter 4-10 cm) were included in this double-blind randomized controlled trial across 17 hospitals in 10 European countries. According to a 2 × 2-factorial design, patients were allocated to 4 arms (open retromuscular or laparoscopic intraperitoneal, with synthetic or Surgisis Gold biological mesh). Patients and outcome assessors were blinded to mesh type used. Major postoperative complication rate (hernia recurrence, mesh infection, or reoperation) within 3 years after surgery, was the primary endpoint in the intention-to-treat population. RESULTS: Between September 1st, 2005, and August 7th, 2009, 253 patients were randomized and 13 excluded. Six of 61 patients (9.8%) in the open synthetic mesh arm, 15 of 66 patients (22.7%) in the open biological mesh arm, 7 of 64 patients (10.9%) in the laparoscopic synthetic mesh arm and 17 of 62 patients (27.4%) in the laparoscopic biological mesh arm had a major complication. The use of biological mesh resulted in significantly more complications (P = 0.013), also after adjusting for hernia type, body mass index, and study site. The trial was prematurely stopped due to an unacceptable high recurrence rate in the biological mesh arms. CONCLUSIONS: The use of Surgisis Gold biological mesh is not recommended for noncomplex ventral hernia repair. TRIAL REGISTRATION: This trial was registered at controlled-trials.com (ISRCTN34532248).
OBJECTIVE: The aim of this study was to investigate the approach (open or laparoscopic) and mesh type (synthetic or biological) in ventral hernias in a clean setting.Summary of Background Data: The level of evidence on the optimal surgical approach and type of mesh in ventral hernia repair is still low. METHODS: Patients with a ventral abdominal hernia (diameter 4-10 cm) were included in this double-blind randomized controlled trial across 17 hospitals in 10 European countries. According to a 2 × 2-factorial design, patients were allocated to 4 arms (open retromuscular or laparoscopic intraperitoneal, with synthetic or Surgisis Gold biological mesh). Patients and outcome assessors were blinded to mesh type used. Major postoperative complication rate (hernia recurrence, mesh infection, or reoperation) within 3 years after surgery, was the primary endpoint in the intention-to-treat population. RESULTS: Between September 1st, 2005, and August 7th, 2009, 253 patients were randomized and 13 excluded. Six of 61 patients (9.8%) in the open synthetic mesh arm, 15 of 66 patients (22.7%) in the open biological mesh arm, 7 of 64 patients (10.9%) in the laparoscopic synthetic mesh arm and 17 of 62 patients (27.4%) in the laparoscopic biological mesh arm had a major complication. The use of biological mesh resulted in significantly more complications (P = 0.013), also after adjusting for hernia type, body mass index, and study site. The trial was prematurely stopped due to an unacceptable high recurrence rate in the biological mesh arms. CONCLUSIONS: The use of Surgisis Gold biological mesh is not recommended for noncomplex ventral hernia repair. TRIAL REGISTRATION: This trial was registered at controlled-trials.com (ISRCTN34532248).