BACKGROUND:Incisional hernia is a frequent complication of abdominal surgery, often requiring surgical intervention. This prospective randomized trial compared suture materials for closure of the fascia after abdominal surgery. METHODS: In 456 patients the abdominal fascia was closed with eithernon-absorbable (polypropylene; Prolene(®)) or absorbable (polydioxanone; PDS(®)) suture material. Follow-up was by clinical examination and ultrasonography at 6-month intervals. Outcome measures were incisional hernia, surgical-site infection and suture sinus. RESULTS: Some 223 patients were analysed after closure with Prolene(®) and 233 after PDS(®) . Median follow-up was 32 and 31 months respectively. There was no significant difference in the incidence of incisional hernia between the groups: 20·2 per cent (45 of 223) for Prolene(®) and 24·9 per cent (58 of 233) with PDS(®) (P = 0·229). Kaplan-Meier analysis showed a cumulative rate after 4 years of 23·7 and 30·2 per cent for Prolene(®) and PDS(®) respectively (P = 0·222). Secondary outcome measures showed no significant differences. CONCLUSION: The incidence of incisional hernia in both groups was higher than expected from previous literature. There were no significant differences between the two suture methods. REGISTRATION NUMBER: ISRCTN65599814 (http://www.clinical-trials.com).
RCT Entities:
BACKGROUND: Incisional hernia is a frequent complication of abdominal surgery, often requiring surgical intervention. This prospective randomized trial compared suture materials for closure of the fascia after abdominal surgery. METHODS: In 456 patients the abdominal fascia was closed with either non-absorbable (polypropylene; Prolene(®)) or absorbable (polydioxanone; PDS(®)) suture material. Follow-up was by clinical examination and ultrasonography at 6-month intervals. Outcome measures were incisional hernia, surgical-site infection and suture sinus. RESULTS: Some 223 patients were analysed after closure with Prolene(®) and 233 after PDS(®) . Median follow-up was 32 and 31 months respectively. There was no significant difference in the incidence of incisional hernia between the groups: 20·2 per cent (45 of 223) for Prolene(®) and 24·9 per cent (58 of 233) with PDS(®) (P = 0·229). Kaplan-Meier analysis showed a cumulative rate after 4 years of 23·7 and 30·2 per cent for Prolene(®) and PDS(®) respectively (P = 0·222). Secondary outcome measures showed no significant differences. CONCLUSION: The incidence of incisional hernia in both groups was higher than expected from previous literature. There were no significant differences between the two suture methods. REGISTRATION NUMBER: ISRCTN65599814 (http://www.clinical-trials.com).
Authors: Kevin W Y van Barneveld; Ruben R M Vogels; Geerard L Beets; Stephanie O Breukink; Jan-Willem M Greve; Nicole D Bouvy; Marc H F Schreinemacher Journal: Surg Endosc Date: 2013-12-20 Impact factor: 4.584
Authors: F E Muysoms; E B Deerenberg; E Peeters; F Agresta; F Berrevoet; G Campanelli; W Ceelen; G G Champault; F Corcione; D Cuccurullo; A C DeBeaux; U A Dietz; R J Fitzgibbons; J F Gillion; R-D Hilgers; J Jeekel; I Kyle-Leinhase; F Köckerling; V Mandala; A Montgomery; S Morales-Conde; R K J Simmermacher; V Schumpelick; M Smietański; M Walgenbach; M Miserez Journal: Hernia Date: 2013-05-15 Impact factor: 4.739