Leeds Institute of Medical Research at St. James's, University of Leeds, Leeds, UK
West Riding of Yorkshire Ileostomy Association, Leeds, UK.
BMJ Open. 2021 Jul 21;11(7):e046313. doi: 10.1136/bmjopen-2020-046313.
Ileus is a common and distressing condition characterised by gut dysfunction after surgery. While a number of interventions have aimed to curtail its impact on patients and healthcare systems, ileus is still an unmet challenge. Electrical stimulation of the vagus nerve is a promising new treatment due to its role in modulating the neuro-immune axis through a novel anti-inflammatory reflex. The protocol for a feasibility study of non-invasive vagus nerve stimulation (nVNS), and a programme of mechanistic and qualitative studies, is described.
This is a participant-blinded, parallel-group, randomised, sham-controlled feasibility trial (IDEAL Stage 2b) of self-administered nVNS. One hundred forty patients planned for elective, minimally invasive, colorectal surgery will be randomised to four schedules of nVNS before and after surgery. Feasibility outcomes include assessments of recruitment and attrition, adequacy of blinding and compliance to the intervention. Clinical outcomes include bowel function and length of hospital stay. A series of mechanistic substudies exploring the impact of nVNS on inflammation and bowel motility will inform the design of the final stimulation schedule. Semistructured interviews with participants will explore experiences and perceptions of the intervention, while interviews with patients who decline participation will explore barriers to recruitment.
The protocol has been approved by the Tyne and Wear South National Health Service (NHS) Research Ethics Committee (19/NE/0217) on 2 July 2019. Feasibility, mechanistic and qualitative findings will be disseminated to national and international partners through peer-reviewed publications, academic conferences, social media channels and stakeholder engagement activities. The findings will build a case for or against progression to a definitive randomised assessment as well as informing key elements of study design.
ISRCTN62033341.
肠麻痹是一种常见且令人痛苦的术后肠道功能障碍。尽管有许多干预措施旨在减少其对患者和医疗系统的影响，但肠麻痹仍然是一个未满足的挑战。刺激迷走神经是一种有前途的新治疗方法，因为它通过一种新的抗炎反射来调节神经免疫轴。本文描述了一项非侵入性迷走神经刺激（nVNS）可行性研究的方案，以及一项机制和定性研究计划。
这是一项参与者盲法、平行组、随机、假对照可行性试验（IDEAL 阶段 2b），对计划行择期微创结直肠手术的 140 名患者进行术前和术后自我管理 nVNS 随机分组。可行性结果包括招募和失访评估、盲法和干预依从性评估。临床结果包括肠道功能和住院时间。一系列探索 nVNS 对炎症和肠道动力影响的机制亚研究将为最终刺激方案的设计提供信息。对参与者进行半结构式访谈，以探讨他们对干预措施的体验和看法；对拒绝参与的患者进行访谈，以探讨招募障碍。
该方案于 2019 年 7 月 2 日获得泰恩威尔郡南国家卫生服务（NHS）研究伦理委员会（19/NE/0217）的批准。可行性、机制和定性研究结果将通过同行评议的出版物、学术会议、社交媒体渠道和利益相关者参与活动在国家和国际合作伙伴中传播。研究结果将为是否推进确定性随机评估提供依据，并为研究设计的关键要素提供信息。
ISRCTN62033341。
