BACKGROUND: This prospective, clinical, randomized, double-blind study was intended to investigate the impact of the structure and the amount of polypropylene (PP) mesh used in laparoscopic transabdominal preperitonealhernioplastic (TAPP) on physical function and life quality. METHODS:180 male patients with primary inguinal hernia undergoing TAPP were randomized for using a heavyweight (108 g/m(2)), double-filament PP mesh (Prolene, 10 x 15 cm, group A, n = 60), a multifilament, heavyweight variant (116 g/m(2)) of PP mesh (Serapren, 10 x 15 cm, group B, n = 60), or a composite mesh (polyglactin and PP) (Vypro II, 10 x 15 cm, group C, n = 60). We compared in terms of complications (seromas, recurrence rate) and life quality (pain development, physical function). The development of life quality was documented according to the SF-36 Health Survey. The follow-up period was 60 months. RESULTS: The recurrence rate (2.2% overall) during 60-month follow-up was not significantly different between the groups. Convalescence in group A was slower than in groups B and C: mean-term values of the visual scales for pain development were significantly (p < 0.05) higher, incapacity for work was 8.2 days longer, and urological adverse effects were stronger. The mean-term development of life quality was significantly lower in group A up to 12th week postoperatively. There were no significant differences between groups B and C. Beyond the 12th postinterventional week the differences diminished. CONCLUSIONS: The composite mesh does not provide an advantage concerning physical function or pain development in comparison to the multifilament, heavyweight, pure polypropylene mesh. Independently of which mesh was implanted 5% of patients are still suffering from discomfort after 5 years.
RCT Entities:
BACKGROUND: This prospective, clinical, randomized, double-blind study was intended to investigate the impact of the structure and the amount of polypropylene (PP) mesh used in laparoscopic transabdominal preperitoneal hernioplastic (TAPP) on physical function and life quality. METHODS: 180 male patients with primary inguinal hernia undergoing TAPP were randomized for using a heavyweight (108 g/m(2)), double-filament PP mesh (Prolene, 10 x 15 cm, group A, n = 60), a multifilament, heavyweight variant (116 g/m(2)) of PP mesh (Serapren, 10 x 15 cm, group B, n = 60), or a composite mesh (polyglactin and PP) (Vypro II, 10 x 15 cm, group C, n = 60). We compared in terms of complications (seromas, recurrence rate) and life quality (pain development, physical function). The development of life quality was documented according to the SF-36 Health Survey. The follow-up period was 60 months. RESULTS: The recurrence rate (2.2% overall) during 60-month follow-up was not significantly different between the groups. Convalescence in group A was slower than in groups B and C: mean-term values of the visual scales for pain development were significantly (p < 0.05) higher, incapacity for work was 8.2 days longer, and urological adverse effects were stronger. The mean-term development of life quality was significantly lower in group A up to 12th week postoperatively. There were no significant differences between groups B and C. Beyond the 12th postinterventional week the differences diminished. CONCLUSIONS: The composite mesh does not provide an advantage concerning physical function or pain development in comparison to the multifilament, heavyweight, pure polypropylene mesh. Independently of which mesh was implanted 5% of patients are still suffering from discomfort after 5 years.
Authors: Gregory C Ebersole; Evan G Buettmann; Matthew R MacEwan; Michael E Tang; Margaret M Frisella; Brent D Matthews; Corey R Deeken Journal: Surg Endosc Date: 2012-04-27 Impact factor: 4.584
Authors: M M Poelman; B van den Heuvel; J D Deelder; G S A Abis; N Beudeker; R R Bittner; G Campanelli; D van Dam; B J Dwars; H H Eker; A Fingerhut; I Khatkov; F Koeckerling; J F Kukleta; M Miserez; A Montgomery; R M Munoz Brands; S Morales Conde; F E Muysoms; M Soltes; W Tromp; Y Yavuz; H J Bonjer Journal: Surg Endosc Date: 2013-05-25 Impact factor: 4.584
Authors: Gerwin A Bernhardt; Gerald Gruber; Benjamin S Molderings; Herwig Cerwenka; Mathias Glehr; Christian Giessauf; Peter Kornprat; Andreas Leithner; Hans-Jörg Mischinger Journal: Surg Endosc Date: 2013-09-06 Impact factor: 4.584
Authors: Marcel Binnebösel; Klaus T von Trotha; Petra Lynen Jansen; Joachim Conze; Ulf P Neumann; Karsten Junge Journal: Semin Immunopathol Date: 2011-01-12 Impact factor: 9.623