Department of Anaesthesiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
BMJ Open. 2019 Nov 24;9(11):e031837. doi: 10.1136/bmjopen-2019-031837.
Geriatric patients have a pronounced risk to suffer from postoperative complications. While effective risk-specific perioperative measures have been studied in controlled experimental settings, they are rarely found in routine healthcare. This study aims (1) to implement a multicomponent preoperative and intraoperative intervention, and investigate its feasibility, and (2) exploratorily assess the effectiveness of the intervention in routine healthcare.
Feasibility and exploratory effectiveness of the intervention will be investigated in a monocentric, prospective, non-randomised, controlled trial. The intervention includes systematic information for patients and family about measures to prevent postoperative complications; preoperative screening for frailty, malnutrition, strength and mobility with nutrient supplementation and physical exercise (prehabilitation) as needed. Further components focus on potentially inadequate medication, patient blood-management and carbohydrate loading prior to surgery, retainment of orientation aids in the operating room and a geriatric anaesthesia concept. Data will successively be collected from control, implementation and intervention groups. Patients aged 65+ with impending surgery will be included. A sample size of 240, n=80 per group, is planned. Assessments will take place at inclusion and 2, 30 and 180 days after surgery. Mixed-methods analyses will be performed. Exploratory effectiveness will be assessed using mixed segmented regressions. The primary endpoint is functional status. Secondary endpoints include cognitive performance, health-related quality of life, length of inpatient stay and occurrence of postoperative complications. Feasibility will be assessed through semi-structured interviews with staff and patients and quantitative analyses of the data quality, focussing on practicability, acceptance, adoption and fidelity to protocol.
The study will be carried out in accordance with the Helsinki Declaration and to principles of good scientific practice. The Ethics Committee of the Medical Association Hamburg, Germany, approved the protocol (study ID: PV5596). Results will be disseminated in scientific journals and healthcare conferences.
ClinicalTrials.gov Identifier: NCT03325413.
老年患者术后并发症的风险显著增加。虽然在对照实验环境中已经研究了针对特定风险的有效围手术期措施，但这些措施在常规医疗保健中很少实施。本研究旨在：（1）实施一种多组分的术前和术中干预，并调查其可行性，以及（2）探索性评估该干预在常规医疗保健中的效果。
本研究将采用单中心、前瞻性、非随机、对照试验来调查该干预的可行性和探索性有效性。该干预包括对患者和家属进行关于预防术后并发症措施的系统信息教育；术前对虚弱、营养不良、力量和活动能力进行筛查，根据需要进行营养补充和体育锻炼（预康复）；进一步的措施侧重于潜在不适当的药物治疗、患者围手术期血液管理和术前碳水化合物负荷、在手术室保留定向辅助工具以及老年麻醉概念。数据将从对照组、实施组和干预组中依次收集。纳入年龄在 65 岁及以上、即将接受手术的患者。计划每组纳入 240 例患者，每组 80 例。评估将在纳入时以及术后 2、30 和 180 天进行。将采用混合方法分析。采用混合分段回归法评估探索性有效性。主要终点为功能状态。次要终点包括认知表现、健康相关生活质量、住院时间和术后并发症发生情况。通过对员工和患者进行半结构式访谈以及对数据质量进行定量分析，评估可行性，重点关注实用性、可接受性、采用情况和对方案的遵从性。
本研究将遵循赫尔辛基宣言和良好科学实践原则进行。德国汉堡医学会伦理委员会批准了该方案（研究 ID：PV5596）。研究结果将在科学期刊和医疗保健会议上发表。
ClinicalTrials.gov 标识符：NCT03325413。
