Fast-Track Perioperative Care After Elective Colorectal Surgery in Senior Patients. Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- 30-day morbidity according to Dindo-Clavien classification
研究概览
简要总结
Fast-track (FT) surgery is a multimodal, multidisciplinary-team approach to reduce perioperative surgical stress and injury after colorectal surgery, resulting in lower morbidity and enhanced recovery. As fast-track approach could probably be the most beneficial for senior patients to reduce postoperative morbidity and better preserve independency, only scarce information is available in senior population. Therefore a randomized controlled trial is initiated in our institution compare a senior dedicated fast-track approach to modern standard care after colorectal surgery.
详细描述
BACKROUND:
The multimodal concept of fast-track (FT) surgery was developed by Kehlet et al. in the 1990s to reduce perioperative surgical stress after colorectal surgery, resulting in lower morbidity & mortality and enhanced recovery.
The main evidence-based FT components include: pain control optimization by epidural or systemic analgesia, short-acting anesthetics, opioids-sparing analgesia, minimally invasive surgery, preoperative carbohydrate administration, normothermia preservation, individualized i.v goal-directed fluids therapy, no bowel preparation, no routine use of drains, nasogastric tube, urinary catheters, early oral nutrition and active ambulation, as well as a dedicated preoperative counseling defining the FT clinical pathway and discharge criteria.
Many cohort studies, randomized controlled trials, meta-analyses and systematic reviews have demonstrated its safety and efficacy for decreasing morbidity, hospital stay, and improving patient satisfaction as compared to standard care (SC).
Only scarce information, mainly based on RetroPro or controlled clinical trials (CCTs), is available on fast-track perioperative care in senior patients (>70 years) as they already represent 15-18% of western population, and over 40% of colorectal surgeries performed at Geneva University Hospital (HUG).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •senior patients (> or = 70 years at operation)
- •elective colorectal surgery
排除标准
- •emergency, liver-associated, revisional surgeries
- •inability to discern or speak French/English, dementia
- •absolute contraindication to systemic analgesia (severe allergic reaction)
结局指标
主要结局
30-day morbidity according to Dindo-Clavien classification
时间窗: Postoperative day (POD) 0 to 30
Dindo-Clavien classification of postoperative complication (Grade I to V), including mortality (grade V)
次要结局
- Length of hospital stay (LOS)(discharge day)
- Level of independance(POD 0, 30, at 6 and 12 months)
- quality of life (QoL)(POD 0, 30 at 6 and 12 months)
- readmission(until POD 30)
研究者
Sandrine Ostermann
Senior Registrar in Digestive Surgery / MD, PhD, swiss board in surgery (FMH)
University Hospital, Geneva