Secondary peritonitis is a severe condition with a 20–32% reported mortality. The accepted treatment modalities are vacuum-assisted closure (VAC) or primary closure with relaparotomy on-demand (ROD). However, no randomised controlled trial has been completed to compare the two methods potential benefits and disadvantages. This study will be a randomised controlled multicentre trial, including patients aged 18 years or older with purulent or faecal peritonitis confined to at least two of the four abdominal quadrants originating from the small intestine, colon, or rectum. Randomisation will be web-based to either primary closure with ROD or VAC in blocks of 2, 4, and 6. The primary endpoint is peritonitis-related complications within 30 or 90 days and one year after index operation. Secondary outcomes are comprehensive complication index (CCI) and mortality after 30 or 90 days and one year; quality of life assessment by (SF-36) after three and 12 months, the development of incisional hernia after 12 months assessed by clinical examination and CT-scanning and healthcare resource utilisation. With an estimated superiority of 15% in the primary outcome for VAC, 340 patients must be included. Hospitals in Denmark and Europe will be invited to participate. There is no robust evidence for choosing either open abdomen with VAC treatment or primary closure with relaparotomy on-demand in patients with secondary peritonitis. The present study has the potential to answer this important clinical question. The study protocol has been registered at clinicaltrials.gov (NCT03932461). Protocol version 1.0, 9 January 2022.

中文翻译：

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继发性腹膜炎患者的真空辅助闭合与按需再剖腹手术——VACOR 试验：随机对照试验方案

继发性腹膜炎是一种严重的疾病，据报道死亡率为 20-32%。公认的治疗方式是真空辅助闭合 (VAC) 或按需再剖腹手术 (ROD) 的初级闭合。然而，尚未完成随机对照试验来比较这两种方法的潜在利弊。这项研究将是一项随机对照多中心试验，包括 18 岁或以上患有化脓性或粪便性腹膜炎的患者，这些患者局限于源自小肠、结肠或直肠的四个腹部象限中的至少两个象限。随机分组将基于网络，以 2、4 和 6 组为一组进行 ROD 或 VAC 初级闭合。主要终点是指数手术后 30 或 90 天和一年内的腹膜炎相关并发症。次要结果是综合并发症指数 (CCI) 和 30 或 90 天和一年后的死亡率；3 个月和 12 个月后通过 (SF-36) 进行生活质量评估，通过临床检查和 CT 扫描以及医疗资源利用情况评估 12 个月后切口疝的发展。VAC 的主要结果估计有 15% 的优势，必须包括 340 名患者。丹麦和欧洲的医院将被邀请参加。对于继发性腹膜炎患者，没有强有力的证据表明选择开腹联合 VAC 治疗或一期闭合联合按需再剖腹手术。本研究有可能回答这个重要的临床问题。该研究方案已在clinicaltrials.gov (NCT03932461) 上注册。协议版本 1.0，2022 年 1 月 9 日。