Non-invasive vagus nerve stimulation to reduce ileus after colorectal surgery: randomized feasibility trial and efficacy assessment (IDEAL Stage 2B).

IF 2.9 3区医学 Q2 GASTROENTEROLOGY & HEPATOLOGY

Colorectal Disease Pub Date : 2024-10-12 DOI:10.1111/codi.17194

Stephen J Chapman, Mikolaj Kowal, Jack A Helliwell, Sonia Lockwood, Maureen Naylor, Julie Croft, Katherine Farley, Deborah D Stocken, David G Jayne

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引用次数: 0

Abstract

Aim: 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.

Method: 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.

Results: 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.

Conclusion: 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.

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无创迷走神经刺激减少结肠直肠手术后回肠梗阻：随机可行性试验和疗效评估（IDEAL 2B 阶段）。

目的：回肠梗阻的特点是手术后有一段肠道运动障碍期，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，防止平滑肌功能障碍，加速肠道功能的恢复。这项研究探讨了无创迷走神经刺激（nVNS）最终试验的可行性，并对其疗效进行了早期评估：方法：进行了一项自控迷走神经刺激多中心随机可行性试验（IDEAL 2B 阶段）。接受结肠直肠手术的患者在手术前后随机接受 nVNS 或假性 nVNS 治疗。可行性结果包括对招募、依从性、盲法和自然减员的评估。临床结果是对肠道功能和不良事件的评估。所有参与者均接受了 30 天的随访。与患者和医疗专业人员的访谈探讨了可行性障碍和实施方面的观点：共接触了 125 名患者，其中 97 人（77.6%）参加了研究。在所有随机分组中，治疗依从性的中位数为 20 次刺激中的 19 次（四分位距为 17-20 次）。各组的不良反应发生率相似。在这项未获授权的可行性研究中，nVNS 和假治疗恢复肠道功能（如首次排便）所需的时间相似。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治疗的机会。医护人员对解决回肠梗阻问题的积极性也很高：需要对临床疗效进行有力的评估，以证实或反驳 nVNS 的前景，临床前模型已经证明了这一点。这项可行性研究的结论是，对 nVNS 的临床疗效进行明确的随机评估是需要的，也是可行的。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Colorectal Disease 医学-胃肠肝病学

CiteScore

6.10

自引率

11.80%

发文量

406

审稿时长

1.5 months

期刊介绍： Diseases of the colon and rectum are common and offer a number of exciting challenges. Clinical, diagnostic and basic science research is expanding rapidly. There is increasing demand from purchasers of health care and patients for clinicians to keep abreast of the latest research and developments, and to translate these into routine practice. Technological advances in diagnosis, surgical technique, new pharmaceuticals, molecular genetics and other basic sciences have transformed many aspects of how these diseases are managed. Such progress will accelerate. Colorectal Disease offers a real benefit to subscribers and authors. It is first and foremost a vehicle for publishing original research relating to the demanding, rapidly expanding field of colorectal diseases. Essential for surgeons, pathologists, oncologists, gastroenterologists and health professionals caring for patients with a disease of the lower GI tract, Colorectal Disease furthers education and inter-professional development by including regular review articles and discussions of current controversies. Note that the journal does not usually accept paediatric surgical papers.