Abstract Background Incisional hernias cause morbidity and may require further surgery. HART (Hughes Abdominal Repair Trial) assessed the effect of an alternative suture method on the incidence of incisional hernia following colorectal cancer surgery. Methods A pragmatic multicentre single-blind RCT allocated patients undergoing midline incision for colorectal cancer to either Hughes closure (double far–near–near–far sutures of 1 nylon suture at 2-cm intervals along the fascia combined with conventional mass closure) or the surgeon’s standard closure. The primary outcome was the incidence of incisional hernia at 1 year assessed by clinical examination. An intention-to-treat analysis was performed. Results Between August 2014 and February 2018, 802 patients were randomized to either Hughes closure (401) or the standard mass closure group (401). At 1 year after surgery, 672 patients (83.7 per cent) were included in the primary outcome analysis; 50 of 339 patients (14.8 per cent) in the Hughes group and 57 of 333 (17.1 per cent) in the standard closure group had incisional hernia (OR 0.84, 95 per cent c.i. 0.55 to 1.27; P = 0.402). At 2 years, 78 patients (28.7 per cent) in the Hughes repair group and 84 (31.8 per cent) in the standard closure group had incisional hernia (OR 0.86, 0.59 to 1.25; P = 0.429). Adverse events were similar in the two groups, apart from the rate of surgical-site infection, which was higher in the Hughes group (13.2 versus 7.7 per cent; OR 1.82, 1.14 to 2.91; P = 0.011). Conclusion The incidence of incisional hernia after colorectal cancer surgery is high. There was no statistical difference in incidence between Hughes closure and mass closure at 1 or 2 years. Registration number ISRCTN25616490 (http://www.controlled-trials.com).

中文翻译：

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根据缝合技术结直肠癌术后切口疝：休斯腹部修复随机试验 (HART)

摘要 背景切口疝会导致发病，可能需要进一步手术。HART（休斯腹部修复试验）评估了替代缝合方法对结直肠癌手术后切口疝发生率的影响。 方法一项务实的多中心单盲随机对照试验将接受中线切口治疗结直肠癌的患者分配至休斯缝合（沿筋膜以 2 厘米间隔用 1 根尼龙缝线进行双远-近-近-远缝合，结合传统肿块缝合）或外科医生的缝合标准闭合。主要结局是通过临床检查评估的 1 年切口疝发生率。进行了意向治疗分析。 结果2014 年 8 月至 2018 年 2 月期间，802 名患者被随机分配至 Hughes 闭合组 (401) 或标准质量闭合组 (401)。术后 1 年，672 名患者（83.7%）被纳入主要结果分析；Hughes 组 339 名患者中有 50 名（14.8%）患有切口疝，标准闭合组 333 名患者中有 57 名（17.1%）患有切口疝（OR 0.84，95% CI 0.55 至 1.27；P = 0.402）。2 年时，Hughes 修复组有 78 名患者（28.7%）和标准闭合组有 84 名患者（31.8%）患有切口疝（OR 0.86，0.59 至 1.25；P = 0.429）。两组的不良事件相似，但休斯组的手术部位感染率较高（13.2% vs 7.7%；OR 1.82、1.14 至 2.91；P = 0.011）。 结论结直肠癌术后切口疝的发生率较高。Hughes 闭合术和肿块闭合术在 1 年或 2 年时的发生率没有统计学差异。 注册号码ISRCTN25616490 (http://www.controlled-trials.com)。