Chapman Stephen J, Kowal Mikolaj, Helliwell Jack A, Lockwood Sonia, Naylor Maureen, Croft Julie, Farley Katherine, Stocken Deborah D, Jayne David G
Leeds Institute of Medical Research, University of Leeds, Leeds, UK.
Bradford Teaching Hospitals NHS Foundation Trust, Bradford, UK.
Colorectal Dis. 2024 Dec;26(12):2101-2111. doi: 10.1111/codi.17194. Epub 2024 Oct 12.
Ileus is characterized by a period of intestinal dysmotility after surgery, leading to vomiting and constipation. In preclinical models, vagus nerve stimulation reduces intestinal inflammation and prevents smooth muscle dysfunction, accelerating the return of gut function. This study explored the feasibility of a definitive trial of non-invasive vagus nerve stimulation (nVNS) along with an early assessment of efficacy.
A multicentre, randomized feasibility trial (IDEAL Stage 2B) of self-administered nVNS was performed. Patients undergoing colorectal surgery were randomized to nVNS or sham before and after surgery. Feasibility outcomes comprised assessments of recruitment, compliance, blinding and attrition. Clinical outcomes were measures of intestinal function and adverse events. All participants were followed up for 30 days. Interviews with patients and health professionals explored barriers to feasibility and perspectives around implementation.
In all, 125 patients were approached about the study and 97 (77.6%) took part. Across all randomized groups, the median compliance to treatment was 19 out of 20 stimulations (interquartile range 17-20). The incidence of adverse events was similar across groups. In this unpowered feasibility study, the time taken for the return of gut function (such as first passage of stool) was similar between nVNS and sham treatments. According to interviews, patients were highly motivated to use the device because it provided them with an opportunity to engage actively in their care. Health professionals were highly driven to tackle the problem of ileus.
Powered assessments of clinical efficacy are required to confirm or refute the promise of nVNS, as already demonstrated in preclinical models. This feasibility study concludes that a definitive randomized assessment of the clinical benefits of nVNS is desired and feasible.
肠梗阻的特征是术后出现一段肠动力障碍期，导致呕吐和便秘。在临床前模型中，迷走神经刺激可减轻肠道炎症并预防平滑肌功能障碍，加速肠道功能恢复。本研究探讨了进行非侵入性迷走神经刺激（nVNS）确定性试验的可行性，并对疗效进行了早期评估。
进行了一项关于自我管理nVNS的多中心随机可行性试验（IDEAL 2B期）。接受结直肠手术的患者在手术前后被随机分为nVNS组或假刺激组。可行性结果包括对招募、依从性、盲法和损耗的评估。临床结果为肠道功能指标和不良事件。所有参与者均随访30天。对患者和卫生专业人员的访谈探讨了可行性障碍以及实施方面的观点。
总共约125名患者被邀请参与该研究，97名（77.6%）参与。在所有随机分组中，治疗的中位依从性为20次刺激中有19次（四分位间距为17 - 20）。各组不良事件发生率相似。在这项未进行功效分析的可行性研究中，nVNS组和假刺激组肠道功能恢复（如首次排便）所需时间相似。根据访谈，患者使用该设备的积极性很高，因为这为他们提供了积极参与自身护理的机会。卫生专业人员也积极致力于解决肠梗阻问题。
正如临床前模型中已经证明的那样，需要进行临床疗效的功效评估来证实或反驳nVNS的前景。这项可行性研究得出结论，对nVNS的临床益处进行确定性随机评估是有必要且可行的。
