Francisco Asencio1,2, Juan Carbó3,4, Ramón Ferri3,5, Salvador Peiró3,6,7, Javier Aguiló3,5, Inmaculada Torrijo8,3, Sebastian Barber3,4, Raul Canovas8,3, Juan Carlos Andreu-Ballester8,3. 1. Department of Surgery, Arnau de Vilanova University Hospital, SanClemente 12, 46015, Valencia, Spain. f.asencio@comv.es. 2. Research Department, Arnau de Vilanova University Hospital, Valencia, Spain. f.asencio@comv.es. 3. Research Department, Arnau de Vilanova University Hospital, Valencia, Spain. 4. Department of Surgery, Francesc de Borja Hospital, Gandia, Spain. 5. Department of Surgery, LluisAlcanyís Hospital, Xativa, Spain. 6. Fundación Para el Fomento de la Investigación Sanitaria y Biomédica de la Comunidad Valenciana (FISABIO), Valencia, Spain. 7. Red de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC), Valencia, Spain. 8. Department of Surgery, Arnau de Vilanova University Hospital, SanClemente 12, 46015, Valencia, Spain.
Abstract
PURPOSE: Long-term extension of a previous randomized controlled clinical trial comparing open (OVHR) vs. laparoscopic (LVHR) ventral hernia repair, assessing recurrence, reoperation, mesh-related complications and self-reported quality of life with 10 years of follow-up. METHODS: Eighty-five patients were followed up to assess recurrence (main endpoint), reoperation, mesh complications and death, from the date of index until recurrence, death or study completion, whichever was first. Recurrence, reoperation rates and death were estimated by intention to treat. Mesh-related complications were only assessed in the LVHR group, excluding conversions (intraperitoneal onlay; n = 40). Quality of life, using the European Hernia Society Quality of Life score, was assessed in surviving non-reoperated patients (n = 47). RESULTS: The incidence rates with 10 person-years of follow-up were 21.01% (CI 13.24-33.36) for recurrence, 11.92% (CI: 6.60-21.53) for reoperation and 24.88% (CI 16.81-36.82) for death. Sixty-two percent of recurrences occurred within the first 2 years of follow-up. No significant differences between arms were found in any of the outcomes analyzed. Incidence rate of intraperitoneal mesh complications with 10 person-years of follow-up was 6.15% (CI 1.99-19.09). The mean EuraHS-QoL score with 13.8 years of mean follow-up for living non-reoperated patients was 6.63 (CI 4.50-8.78) over 90 possible points with no significant differences between arms. CONCLUSION: In incisional ventral hernias with wall defects up to 15 cm wide, laparoscopic repair seems to be as safe and effective as open techniques, with no long-term differences in recurrence and reoperation rates or global quality of life, although lack of statistical power does not allow definitive conclusions on equivalence between alternatives. TRIAL REGISTRATION NUMBER: ClinicalTrial.gov (NCT04192838).
PURPOSE: Long-term extension of a previous randomized controlled clinical trial comparing open (OVHR) vs. laparoscopic (LVHR) ventral hernia repair, assessing recurrence, reoperation, mesh-related complications and self-reported quality of life with 10 years of follow-up. METHODS: Eighty-five patients were followed up to assess recurrence (main endpoint), reoperation, mesh complications and death, from the date of index until recurrence, death or study completion, whichever was first. Recurrence, reoperation rates and death were estimated by intention to treat. Mesh-related complications were only assessed in the LVHR group, excluding conversions (intraperitoneal onlay; n = 40). Quality of life, using the European Hernia Society Quality of Life score, was assessed in surviving non-reoperated patients (n = 47). RESULTS: The incidence rates with 10 person-years of follow-up were 21.01% (CI 13.24-33.36) for recurrence, 11.92% (CI: 6.60-21.53) for reoperation and 24.88% (CI 16.81-36.82) for death. Sixty-two percent of recurrences occurred within the first 2 years of follow-up. No significant differences between arms were found in any of the outcomes analyzed. Incidence rate of intraperitoneal mesh complications with 10 person-years of follow-up was 6.15% (CI 1.99-19.09). The mean EuraHS-QoL score with 13.8 years of mean follow-up for living non-reoperated patients was 6.63 (CI 4.50-8.78) over 90 possible points with no significant differences between arms. CONCLUSION: In incisional ventral hernias with wall defects up to 15 cm wide, laparoscopic repair seems to be as safe and effective as open techniques, with no long-term differences in recurrence and reoperation rates or global quality of life, although lack of statistical power does not allow definitive conclusions on equivalence between alternatives. TRIAL REGISTRATION NUMBER: ClinicalTrial.gov (NCT04192838).
Authors: Frank Peinemann; Ulrich Grouven; Lars G Hemkens; Carmen Bartel; Holger Borchers; Michael Pinkawa; Axel Heidenreich; Stefan Sauerland Journal: Cochrane Database Syst Rev Date: 2011-07-06
Authors: Julia B Kössler-Ebs; Kathrin Grummich; Katrin Jensen; Felix J Hüttner; Beat Müller-Stich; Christoph M Seiler; Phillip Knebel; Markus W Büchler; Markus K Diener Journal: World J Surg Date: 2016-10 Impact factor: 3.352
Authors: William W Hope; Adel G El-Ghazzawy; Brad A Winterstein; Jeffrey A Blatnik; S Scott Davis; Jacob A Greenberg; Noel C Sanchez; Eric M Pauli; Daniel M Tseng; Karl A LeBlanc; Kurt E Roberts; Curtis E Bower; Eduardo Parra-Davila; J Scott Roth; Corey R Deeken; Eric F Smith Journal: Ann Med Surg (Lond) Date: 2021-12-06