Three-year follow-up analysis of the short-stitch versus long-stitch technique for elective midline abdominal closure randomized-controlled (ESTOIH) trial
René H. Fortelny, Anna Hofmann, Petra Baumann, Stefan Riedl, Jan Ludolf Kewer, Jessica Hoelderle, Andreas Shamiyeh, Bettina Klugsberger, Tara Maier, Guido Schumacher, F. Köckerling, Ursula Pession, Malte Schirren, Markus Albertsmeier
Abstract
BACKGROUND: Clinical trials have shown reduced incisional hernia rates 1 year after elective median laparotomy closure using a short-stitch technique. With hernia development continuing beyond the first postoperative year, we aimed to compare incisional hernias 3 years after midline closure using short or long stitches in patients from the ESTOIH trial. METHODS: The ESTOIH trial was a prospective, multicenter, parallel-group, double-blind, randomized-controlled study of primary elective midline closure. Patients were randomized to fascia closure using a short- or long-stitch technique with a poly-4-hydroxybutyrate-based suture. A predefined 3-year follow-up analysis was performed with the radiological imaging-verified incisional hernia rate as the primary endpoint. RESULTS: The 3-year intention-to-treat follow-up cohort consisted of 414 patients (210 short-stitch and 204 long-stitch technique) for analysis. Compared with 1 year postoperatively, incisional hernias increased from 4.83% (20/414 patients) to 9.02% (36/399 patients, p = 0.0183). The difference between the treatment groups at 3 years (short vs. long stitches, 15/198 patients (7.58%) vs. 21/201 (10.45%)) was not significant (OR, 1.4233; 95% CI [0.7112-2.8485]; p = 0.31). CONCLUSION: Hernia rates increased significantly between one and 3 years postoperatively. The short-stitch technique using a poly-4-hydroxybutyrate-based suture is safe in the long term, while no significant advantage was found at 3 years postoperatively compared with the standard long-stitch technique. TRIAL REGISTRY: NCT01965249, registered on 18 October 2013.