5-year clinical outcome of the ESTOIH trial comparing the short-bite versus large-bite technique for elective midline abdominal closure.

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.