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微创结直肠癌手术后加速强化康复():一项新型随机对照试验的研究方案

Accelerated enhanced y following inimally nvasive colorectal cancer surgery (): a study protocol for a novel randomised controlled trial.

作者信息

Price Brandee A, Bednarski Brian K, You Y Nancy, Manandhar Meryna, Dean E Michelle, Alawadi Zeinab M, Bryce Speer B, Gottumukkala Vijaya, Weldon Marla, Massey Robert L, Wang Xuemei, Qiao Wei, Chang George J

机构信息

Department of Surgical Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.

Clinical Cancer Genetics, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.

出版信息

BMJ Open. 2017 Jul 20;7(7):e015960. doi: 10.1136/bmjopen-2017-015960.

Abstract

INTRODUCTION

Definitive treatment of localised colorectal cancer involves surgical resection of the primary tumour. Short-stay colectomies (eg, 23-hours) would have important implications for optimising the efficiency of inpatient care with reduced resource utilisation while improving the overall recovery experience with earlier return to normalcy. It could permit surgical treatment of colorectal cancer in a wider variety of settings, including hospital-based ambulatory surgery environments. While a few studies have shown that discharge within the first 24 hours after minimally invasive colectomy is possible, the safety, feasibility and patient acceptability of a protocol for short-stay colectomy for colorectal cancer have not previously been evaluated in a prospective randomised study. Moreover, given the potential for some patients to experience a delay in recovery of bowel function after colectomy, close outpatient monitoring may be necessary to ensure safe implementation.

METHODS AND ANALYSIS

In order to address this gap, we propose a prospective randomised trial of accelerated enhanced y following inimally nvasive colorectal cancer surgery () that leverages the combination of minimally invasive surgery with enhanced recovery protocols and early coordinated outpatient remote televideo conferencing technology () to improve postoperative patien-provider communication, enhance postoperative treatment navigation and optimise postdischarge care. We hypothesise that RecoverMI can be safely incorporated into multidisciplinary practice to improve patient outcomes and reduce the overall 30-day duration of hospitalisation while preserving the quality of the patient experience. ETHICS AND DISSEMINATION: has received institutional review board approval and funding from the American Society of Colorectal Surgeons (ASCRS; LPG103). Results from RecoverMI will be published in a peer-reviewed publication and be used to inform a multisite trial.

TRIAL REGISTRATION NUMBER

NCT02613728; Pre-results.

摘要

引言

局部结直肠癌的确定性治疗包括对原发性肿瘤进行手术切除。短期住院结肠切除术(例如23小时)对于优化住院护理效率、减少资源利用,同时通过更早恢复正常来改善整体康复体验具有重要意义。它可以在更广泛的环境中开展结直肠癌的手术治疗,包括医院门诊手术环境。虽然一些研究表明,微创结肠切除术后24小时内出院是可行的,但此前尚未在前瞻性随机研究中评估结直肠癌短期住院结肠切除方案的安全性、可行性和患者可接受性。此外,鉴于一些患者在结肠切除术后可能出现肠功能恢复延迟,可能需要密切的门诊监测以确保安全实施。

方法与分析

为了填补这一空白,我们提出一项前瞻性随机试验,即加速强化微创结直肠癌手术后的恢复(RecoverMI),该试验利用微创手术与强化康复方案以及早期协调的门诊远程视频会议技术(eVTC)相结合,以改善术后医患沟通、加强术后治疗指导并优化出院后护理。我们假设RecoverMI可以安全地纳入多学科实践,以改善患者预后、缩短整体30天住院时间,同时保持患者体验的质量。伦理与传播:RecoverMI已获得机构审查委员会批准,并获得美国结直肠外科医师协会(ASCRS;LPG103)的资助。RecoverMI的结果将发表在同行评审的出版物上,并用于为多中心试验提供参考。

试验注册号

NCT02613728;结果未公布。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3717/5642654/b3340043223c/bmjopen-2017-015960f01.jpg

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