RECUPERA-C Study: Protocol: Personalised and Controlled Rapid Recovery After Colorectal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 97
- 主要终点
- Proportion of patients fulfilling all predefined clinical and functional criteria for early discharge (≤48 hours after surgery)
研究概览
简要总结
RECUPERA-C is a prospective observational pilot study evaluating the feasibility and safety of an early discharge strategy within 48 hours after minimally invasive colorectal surgery. The study will assess whether patients can meet predefined clinical and functional discharge criteria, and will identify factors that may prevent early discharge. C-reactive protein and neutrophil-to-lymphocyte ratio will also be evaluated as exploratory markers of postoperative complications.
详细描述
RECUPERA-C is a prospective observational cohort study conducted within an established Enhanced Recovery After Surgery (ERAS) program. The study will include adult patients undergoing elective major colorectal surgery through a minimally invasive approach.
The study will evaluate a structured early discharge protocol based on predefined clinical and functional criteria. Patients will be assessed during the first 48 hours after surgery to determine whether they meet the conditions considered necessary for safe discharge. These criteria include clinical stability, adequate pain and nausea control, oral intake, gastrointestinal recovery, and functional recovery.
Patients will be followed prospectively for 30 days after surgery. The study will evaluate the proportion of patients meeting the early discharge criteria, the actual early discharge rate, reasons for prolonged hospitalisation, total length of stay, postoperative complications, readmissions, healthcare resource utilisation, and patient satisfaction.
C-reactive protein and neutrophil-to-lymphocyte ratio will be collected as exploratory biomarkers to assess their potential association with postoperative complications and their possible role as complementary tools for risk stratification.
The study will also identify clinical, functional, social, and organisational factors that may limit implementation of the early discharge strategy. The overall aim is to determine whether a structured discharge pathway within an ERAS programme can safely and feasibly reduce hospital stay to 48 hours or less after minimally invasive colorectal surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age ≥18 years.
- •Elective major colorectal surgery for benign or malignant disease.
- •Minimally invasive approach (laparoscopic or robotic).
- •ASA physical status I-III.
- •Functional independence in basic activities of daily living.
- •Adequate home support and the ability to access and return to the hospital if required.
- •Adequate understanding of the perioperative plan.
- •Written informed consent.
排除标准
- •Emergency surgery.
- •Significant intraoperative complications.
- •Major multivisceral resections.
- •New ostomy creation.
- •Functional dependence or significant cognitive impairment.
- •Decompensation of major comorbidities.
- •Anticipated need for postoperative admission to an intensive care unit.
- •Social circumstances that may make early discharge unsafe.
研究组 & 干预措施
Colorectal Surgery Patients
Adult patients undergoing elective major minimally invasive colorectal surgery. A structured early discharge pathway (≤48 hours) will be applied based on predefined clinical and functional criteria.
结局指标
主要结局
Proportion of patients fulfilling all predefined clinical and functional criteria for early discharge (≤48 hours after surgery)
时间窗: Within 48 hours after surgery
Proportion of patients fulfilling all predefined clinical and functional criteria for early discharge (≤48 hours after surgery)
次要结局
未报告次要终点