文献检索文档翻译深度研究
Suppr Zotero 插件Zotero 插件
邀请有礼套餐&价格历史记录

新学期,新优惠

限时优惠:9月1日-9月22日

30天高级会员仅需29元

1天体验卡首发特惠仅需5.99元

了解详情
不再提醒
插件&应用
Suppr Zotero 插件Zotero 插件浏览器插件Mac 客户端Windows 客户端微信小程序
高级版
套餐订阅购买积分包
AI 工具
文献检索文档翻译深度研究
关于我们
关于 Suppr公司介绍联系我们用户协议隐私条款
关注我们

Suppr 超能文献

核心技术专利:CN118964589B侵权必究
粤ICP备2023148730 号-1Suppr @ 2025

非侵入性迷走神经刺激减少结直肠手术后肠梗阻:随机可行性试验及疗效评估(IDEAL 2B期)

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

作者信息

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

机构信息

Leeds Institute of Medical Research, University of Leeds, Leeds, UK.

Bradford Teaching Hospitals NHS Foundation Trust, Bradford, UK.

出版信息

Colorectal Dis. 2024 Dec;26(12):2101-2111. doi: 10.1111/codi.17194. Epub 2024 Oct 12.


DOI:10.1111/codi.17194
PMID:39394910
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11649866/
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.

摘要

目的: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。 方法: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。 结果: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。 结论: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。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3546/11649866/5c2ec53ddda1/CODI-26-2101-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3546/11649866/3a84c33770d4/CODI-26-2101-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3546/11649866/cc5296f48157/CODI-26-2101-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3546/11649866/5c2ec53ddda1/CODI-26-2101-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3546/11649866/3a84c33770d4/CODI-26-2101-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3546/11649866/cc5296f48157/CODI-26-2101-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3546/11649866/5c2ec53ddda1/CODI-26-2101-g003.jpg

相似文献

[1]
Non-invasive vagus nerve stimulation to reduce ileus after colorectal surgery: randomized feasibility trial and efficacy assessment (IDEAL Stage 2B).

Colorectal Dis. 2024-12

[2]
Non-invasive, vagus nerve stimulation to reduce ileus after colorectal surgery: protocol for a feasibility trial with nested mechanistic studies.

BMJ Open. 2021-7-21

[3]
Noninvasive vagus nerve stimulation to reduce ileus after major colorectal surgery: early development study.

Colorectal Dis. 2021-5

[4]
Assessment of safety and feasibility of non-invasive vagus nerve stimulation for treatment of acute stroke.

Brain Stimul. 2022

[5]
Non-invasive vagus nerve stimulation (nVNS) for the preventive treatment of episodic migraine: The multicentre, double-blind, randomised, sham-controlled PREMIUM trial.

Cephalalgia. 2019-9-15

[6]
Consistent effects of non-invasive vagus nerve stimulation (nVNS) for the acute treatment of migraine: additional findings from the randomized, sham-controlled, double-blind PRESTO trial.

J Headache Pain. 2018-11-1

[7]
Practical and clinical utility of non-invasive vagus nerve stimulation (nVNS) for the acute treatment of migraine: a post hoc analysis of the randomized, sham-controlled, double-blind PRESTO trial.

J Headache Pain. 2018-10-19

[8]
Non-invasive vagus nerve stimulation for the acute treatment of episodic and chronic cluster headache: A randomized, double-blind, sham-controlled ACT2 study.

Cephalalgia. 2017-12-12

[9]
Non-Invasive Vagus Nerve Stimulation for the ACute Treatment of Cluster Headache: Findings From the Randomized, Double-Blind, Sham-Controlled ACT1 Study.

Headache. 2016-9

[10]
Non-invasive transcutaneous auricular vagus nerve stimulation prevents postoperative ileus and endotoxemia in mice.

Neurogastroenterol Motil. 2018-11-8

本文引用的文献

[1]
Formation of a conceptual framework during the development of a patient-reported outcome measure for early gastrointestinal recovery: phase I of the PRO-diGi study.

Colorectal Dis. 2023-10

[2]
Low-intensity transcutaneous auricular vagus nerve stimulation reduces postoperative ileus after laparoscopic radical resection of colorectal cancer: a randomized controlled trial.

Minerva Anestesiol. 2023-3

[3]
Core outcome set for clinical studies of postoperative ileus after intestinal surgery.

Br J Surg. 2022-5-16

[4]
Non-invasive, vagus nerve stimulation to reduce ileus after colorectal surgery: protocol for a feasibility trial with nested mechanistic studies.

BMJ Open. 2021-7-21

[5]
Noninvasive vagus nerve stimulation to reduce ileus after major colorectal surgery: early development study.

Colorectal Dis. 2021-5

[6]
Impact of Auricular Neurostimulation in Patients Undergoing Colorectal Surgery with an Enhanced Recovery Protocol: A Pilot Randomized, Controlled Trial.

Dis Colon Rectum. 2021-2-1

[7]
Placebo Response Rates in Electrical Nerve Stimulation Trials for Fecal Incontinence and Constipation: A Systematic Review and Meta-Analysis.

Neuromodulation. 2020-12

[8]
Safety and efficacy of non-steroidal anti-inflammatory drugs to reduce ileus after colorectal surgery.

Br J Surg. 2020-1

[9]
Effect of transcutaneous vagus nerve stimulation on muscle activity in the gastrointestinal tract (transVaGa): a prospective clinical trial.

Int J Colorectal Dis. 2019-3

[10]
Characterising and justifying sample size sufficiency in interview-based studies: systematic analysis of qualitative health research over a 15-year period.

BMC Med Res Methodol. 2018-11-21

文献AI研究员

20分钟写一篇综述,助力文献阅读效率提升50倍

立即体验

用中文搜PubMed

大模型驱动的PubMed中文搜索引擎

马上搜索

推荐工具

医学文档翻译智能文献检索