5-year clinical outcome of the ESTOIH trial comparing the short-bite versus large-bite technique for elective midline abdominal closure
René H. Fortelny, Petra Baumann, Anna Hofmann, Stefan Riedl, Jan Ludolf Kewer, Jessica Hoelderle, Andreas Shamiyeh, Bettina Klugsberger, Theo Maier, Guido Schumacher, Ferdinand Köckerling, Guido Wöste, Ursula Pession, Markus Albertsmeier
Abstract
BACKGROUND: The short-bite technique for fascial closure after midline laparotomy has been shown to reduce the incidence of incisional hernias one year postoperatively compared to the traditional large-bite technique. However, most studies evaluating this approach have been limited to a one-year follow-up period. Initiated in 2013, the ESTOIH trial is the only randomised controlled study to include both 3-year and 5-year follow-up data. The 3-year clinical outcomes have been previously published. Herein, we report for the first time the 5-year results regarding the incisional hernia rate using the small-bite technique compared to the large-bite technique for elective midline closure. METHODS: The ESTOIH study was designed as a prospective, multicentre, parallel, double-blind, randomised controlled study of primary elective midline closure. Patients were randomly assigned to receive either the small-bite or large-bite technique to close the fascia using an ultra-long-term, absorbable, elastic, monofilament suture named Monomax® based on poly-4-hydroxybutyrate. A planned 5-year follow-up was conducted, including ultrasound/radiological imaging to assess incisional hernia development as a key outcome parameter for the long-term effectiveness of the procedure. RESULTS: In total, 362 patients were included in the 5-year ITT analysis (175 and 187 patients in the short-bite and large-bite groups, respectively). The incisional hernia rate increased in the short-bite group from 7.58% to 9.14% (p = 0.58) and in the large-bite group from 10.45% to 13.90% (p = 0.30) after 5 years compared to 3 years postoperatively. The incisional hernia rate in the short-stitch group was low, at 9.14% five years after surgery; however, the difference between the two treatment groups (short vs. long) was not significant at 5 years (OR 1.60, 95% CI [0.82-3.10]; p = 0.155). CONCLUSION: The previously observed increase in incisional hernias from 1 to 3 years postoperatively continued to 5 years in both stitch groups. The incisional hernia rate in the long-stitch group appeared to be higher at every time point than that in the short-stitch group. Using the short-bite technique in combination with an extra-long-term absorbable, elastic, monofilament poly-4-hydroxybutyrate suture, it may be possible to achieve a very low incisional hernia rate in the long-term follow-up. TRIAL REGISTRY: NCT01965249, registered October 18, 2013.