Effect of Tailored, Intensive Prehabilitation for Risky Lifestyles Before Ventral Hernia Repair on Postoperative Outcomes, Health, and Costs - a Randomised Controlled Trial (STRONG-Hernia)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 3
- 主要终点
- Postoperative complications within 30 days
研究概览
简要总结
The five risky lifestyles Smoking, Nutrition (obesity and malnutrition), risky Alcohol intake, and Physical inactivity (SNAP) are common in surgical patients and associated with worse postoperative outcomes. Mono-factor interventions targeting and improving these risky lifestyles have been shown to reduce the risk at surgery, but there is a lack of systematic assessment of all five lifestyles of the patient before surgery and related optimization.
This study aims to evaluate the effect of intensive combined lifestyle interventions (the STRONG programme) compared with treatment as usual in patients undergoing ventral hernia repair on postoperative complications, health, and costs on short and longer term.
The hypothesis is that the STRONG programme will halve the complication rates within 30 days.
详细描述
This study is a multicentre randomised controlled trial. A total of 400 participants with one or more of the five risky SNAP lifestyles will be randomised to either the STRONG programme (a prehabilitation intervention) or treatment as usual preoperatively (control). The STRONG programme is individually tailored to the needs of the participants. The program contains education, motivational, and pharmaceutical support. All participants will be followed up at the end of the intervention/at surgery, one, three, and six months after surgery. Long-term outcomes are followed up from national registers two years after surgery.
Interim analysis will be employed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
Statistical analyses will be conducted blinded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants ≥18 years scheduled for ventral hernia repair (defect smaller than 8cm)
- •Enough time for at least 4 weeks of prehabilitation
- •Screened positive for at least 1 risky SNAP factor
- •Signed informed consent
排除标准
- •Ventral hernia repairs with defect larger than 8 cm
- •Pregnancy/breastfeeding
- •Allergy/other contradiction to pharmaceutical and/or nutritional support
- •Contradiction to exercise
- •Previous complicated alcohol withdrawal symptoms (delirium or seizures)
- •Not able to participate in intervention due to psychiatric ilness
研究组 & 干预措施
Prehabilitation
Intervention (the STRONG programme): At least six counselling sessions (around one per week) prior to surgery as an integrated prehabilitation programme tailored to the individual patient's need for risk reduction at surgery based on a baseline screening for risky SNAP factors. It is delivered via the surgical "Engage in the process of change". The smoking cessation intervention follows the Gold Standard Programme and a similar structure has been used for alcohol cessation, physical exercise, and nutrition interventions. All participants in the intervention group will receive immunonutrition in the days before surgery.
干预措施: Prehabilitation (the STRONG programme) (Behavioral)
Treatment as usual
Treatment as usual in the preoperative period in the included hospital departments, e.g. brief counselling/advice regarding smoking cessation and weight loss, and handing out the national folders on smoking and surgery. Participants are free to access support to lifestyle changes in the community.
结局指标
主要结局
Postoperative complications within 30 days
时间窗: 30 days
Number and proportion of participants with at least one postoperative complication defined by requiring treatment
次要结局
- Any improvement of risky lifestyles(End of intervention/at surgery, 30 days, 3 months, 6 months)
- Postoperative complications within 3 and 6 months(3 months, 6 months)
- Comprehensive Complication Index (CCI)(30 days, 3 months, 6 months)
- Successful quitting of risky lifestyles(End of intervention/at surgery, 30 days, 3 months, 6 months)
- Health-Related Quality of Life (HRQoL)(End of intervention/at surgery, 30 days, 3 months, 6 months)
- Costs(30 days, 6 months, 2 years)
- Cost-effectiveness(2 years)
- Patient expectations(Baseline)
- Patient reflections 1(Baseline)
- Patient reflections 2(Baseline)
研究者
Hanne Tonnesen
Clinical Professor, MD
Bispebjerg Hospital