Jensen Sofie Anne-Marie Skovbo, Lauridsen Susanne Vahr, Fonnes Siv, Rosenberg Jacob, Tønnesen Hanne
WHO-CC/Clinical Health Promotion Centre, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Frederiksberg, Denmark.
Department of Surgery, Centre for Perioperative Optimization, University of Copenhagen, Herlev Hospital, Herlev, Denmark.
PLoS One. 2025 May 28;20(5):e0324002. doi: 10.1371/journal.pone.0324002. eCollection 2025.
A substantial untapped potential for risk reduction may be fulfilled by applying intensive lifestyle interventions targeting the co-existing risky lifestyle factors Smoking, Nutrition (both malnutrition and obesity), risky Alcohol intake, and Physical inactivity (SNAP) before surgery. This trial will compare the effect of combined and individually tailored prehabilitation with standard care on postoperative outcomes, health, and cost-effectiveness in short and long term in participants undergoing ventral hernia repair. An interview study will be nested within the randomised trial.
The study is a multicenter, parallel-group, superiority randomised clinical trial. A total of 400 adult participants undergoing ventral hernia repair with ≥1 SNAP factor will be allocated to the individually tailored STRONG programme or standard care. The STRONG programme is initiated at least four weeks prior to surgery and consists of six sessions. It is delivered as one session a week, approximately, and includes patient education, motivational, and pharmaceutical supports. The primary outcome is postoperative complications requiring treatment within 30 days. Secondary outcomes address other surgical outcomes, changes in lifestyle, health, and cost-effectiveness. Follow-up takes place after 6 weeks (the end of intervention), at surgery, and 30 days, 90 days, and 6 months after surgery, respectively. Long-term data on health and costs will be obtained from nationwide registries after two years. Eligible trial participants will be invited to a semi-structured interview study at baseline. Their reflections on the STRONG programme and the choice of participating in the trial or not will be explored.
Many patients have multiple SNAP factors adding to the risk of complications related to surgery. As these are modifiable, prehabilitation may be an area with great potential for risk reduction. Nevertheless, no well-acknowledged and evidence-based strategies exist in the preoperative period. The STRONG programme is tailored specifically to the individual patient's preidentified needs including up to all five common risky SNAP factors and may tap into the large unused potential for risk reduction. Overall, the study will add important new knowledge on the effect of individually tailored prehabilitation on complications and other important outcomes in elective surgery, and also clarify if this intervention will have long-lasting implications.
www.clinicaltrials.gov (NCT06611462).
通过在手术前针对同时存在的吸烟、营养（包括营养不良和肥胖）、危险饮酒和身体活动不足（SNAP）等危险生活方式因素进行强化生活方式干预，可能实现大幅降低风险的未开发潜力。本试验将比较在接受腹疝修补术的参与者中，联合及个体化定制的术前康复与标准护理对术后短期和长期结局、健康状况及成本效益的影响。一项访谈研究将嵌套在该随机试验中。
本研究为多中心、平行组、优效性随机临床试验。共有400名伴有≥1个SNAP因素且接受腹疝修补术的成年参与者将被分配至个体化定制的STRONG方案组或标准护理组。STRONG方案在手术前至少四周开始，包括六个疗程。大约每周进行一个疗程，包括患者教育、激励和药物支持。主要结局是术后30天内需要治疗的并发症。次要结局涉及其他手术结局、生活方式、健康状况的变化以及成本效益。分别在6周（干预结束时）、手术时、术后30天、90天和6个月进行随访。两年后将从全国登记处获取健康和成本的长期数据。符合条件的试验参与者将在基线时被邀请参加一项半结构化访谈研究。将探讨他们对STRONG方案的看法以及参与或不参与试验的选择。
许多患者存在多个SNAP因素，增加了与手术相关的并发症风险。由于这些因素是可改变的，术前康复可能是一个具有巨大降低风险潜力的领域。然而，在术前阶段尚无公认的、基于证据的策略。STRONG方案是专门针对个体患者预先确定的需求制定的，包括多达所有五个常见的危险SNAP因素，可能挖掘出大量未被利用的降低风险潜力。总体而言，本研究将为个体化定制的术前康复对择期手术并发症及其他重要结局的影响增添重要新知识，并阐明该干预措施是否会产生长期影响。
