Small Bites vs Large Bites for Closure of Abdominal Midline Incisions: A Randomized Clinical Trial

Abstract

Importance: Incisional hernia after midline laparotomy causes long-term morbidity and reduced quality of life; closure technique may affect long-term risk. Superiority of the small-bites fascial closure technique in reducing incisional hernia rate at 1 year after midline laparotomy was previously demonstrated in the STITCH trial. Objective: To evaluate incisional hernia incidence 13 years after accrual ended. Design, Setting, and Participants: This multicenter, double-blind randomized clinical trial took place between October 2009 and March 2012 at 10 participating centers in the Netherlands, including surgical and gynecological departments. The study included 559 patients undergoing elective midline laparotomy. These data were analyzed from January 2025 through June 2025. Interventions: Continuous small-bites fascial closure (5 mm × 5 mm, polydioxanone 2-0 on 31-mm needle) vs large bites (10 mm × 10 mm, looped polydioxanone on 48-mm needle) in the control group. Main Outcomes and Measures: Primary outcome was cumulative incidence of incisional hernia (clinical and radiologic) analyzed with time-to-event methods accounting for competing risks. Secondary outcomes included hernia width, repair rates, and patient-reported quality of life. Results: A total of 275 patients were randomized to small-bites fascial closure and 284 to the control group. Median time to censoring was 8 (IQR, 2-13) years. At final follow-up, 170 patients were alive without evidence of incisional hernia. Of these, 122 (72%) underwent additional abdominal ultrasound. Abdominal imaging performed as part of patient care was available for 238 patients. At 13 years, cumulative incidence of incisional hernia was 34% in the small-bites group and 49% in the large-bites group (hazard ratio, 0.61; 95% CI, 0.43-0.86). Corresponding outcomes for hernia width more than 20 mm were 17% and 34%, respectively (hazard ratio, 0.36; 95%CI, 0.21-0.60). Hernias were significantly smaller after small-bites closure at final follow-up (mean, 25 mm vs 43 mm; P =.02). Hernia repair rates were similar. Patients with an incisional hernia reported significantly lower quality of life. Conclusions and Relevance: In this study, the small-bites technique reduced the long-term risk and width of incisional hernias after elective midline laparotomy. Given its simplicity, cost neutrality, and broad applicability, it should be regarded standard practice. Further research should explore strategies to enhance adoption and assess broader patient-centered outcomes.