此页面是自动翻译的，不保证翻译的准确性。请参阅英文版对于源文本。

PROPOSAL FOR A PREOPERATIVE FUNCTIONAL OPTIMIZATION PATHWAY FOR PATIENTS CANDIDATE FOR MAJOR SURGERY (CARDIAC AND ABDOMINAL ONCOLOGY) (PRIME CARE)

2026年9月25日更新者：Luca Guzzetti、ASST Sette Laghi

PRehabilitation With Integrated and Multimodal Evaluation in Cardiac and Abdominal majoR surgEry (PRIME CARE) A Proposed Pathway for Preoperative Functional Optimization in Candidates for Major Surgery

The study aims to evaluate a prehabilitation protocol for patients undergoing cardiac and abdominal surgery. The project for a preparation program for cardiac surgery was developed within the framework of ERAS (Enhanced Recovery After Surgery), which aims to ensure optimal recovery after surgery and a Surgery), which aims to ensure optimal recovery after surgery and an early and safe return to daily activities.

The study focuses on the preoperative phase, with the introduction of the concept of prehabilitation, i.e., a program to enhance the functional abilities of individuals in preparation for major surgery. The study focuses on the preoperative phase, introducing the concept of prehabilitation, i.e., a program to enhance the functional abilities of individuals in preparation for major surgery, such as cardiac surgery, on an elective basis.

This program, which currently represents best clinical practice, lasts four weeks and addresses several areas: strengthening respiratory and muscular functions, optimizing nutrition, and cognitive stimulation. Patients will be assessed at enrollment and up to 180 days post-surgery to evaluate their clinical status compared to pre-surgery on these four aspects mentioned above.

研究概览

地位

招聘中

条件

研究类型

观察性的

注册 (估计的)

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

姓名：Massimo Stella, MD
电话号码：0039 0332393447
邮箱：maxstella95@gmail.com

学习地点

意大利
- - Varese、意大利、21100
    - 主动，不招人
    - ASST Sette Laghi
- VA
  - Varese、VA、意大利、21052
    - 招聘中
    - Ospedale di Circolo
    - 接触：
      
      Massimo Stella, MD
      
      电话号码：+39 0332 393447
      
      邮箱：maxstella95@gmail.com

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

This prospective, observational, single-center study will enroll approximately 50 adult patients (≥18 years old) undergoing elective cardiac or major abdominal surgery at Ospedale di Circolo e Fondazione Macchi, Varese, Italy. Eligible patients for abdominal surgery must have ASA I-III and PS ECOG ≤2. Key exclusion criteria include emergency surgery, unstable angina, malignant arrhythmias, severe or very severe COPD, dementia, pregnancy, or inability to provide informed consent. Participants will be screened by the surgical team and followed during a personalized prehabilitation program starting about one month before surgery.

描述

Inclusion Criteria:

Elective major abdominal surgery or elective cardio surgery
American Society of Anaesthesiologists Physical Status Classification ≤ 3
Performance Status according to ECOG Scale ≤ 2

Exclusion Criteria:

Emergency surgery
Unstable angina
Malignant arrythmias
Severe/ very severe COPD
Dementia
Pregnancy
Inability to provide informed consent

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

观测模型：CASE_ONLY
时间观点：PROSPECTIVE

团体/队列数

队列和干预

团体/队列
Eligible patients for major surgery

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
10% improvement from baseline at 6-minutes-walking-test-distance 大体时间：From enrollment to the date of surgery	The primary outcome of this study is to evaluate whether prehabilitation translates into an improvement in quality of life before surgery, assessed in terms of functional status. This objective is assessed using the 6-minute walking distance test. A significant improvement is considered to be a positive delta in the six-minute walking test of ≥10% obtained at the assessment performed on the day of admission compared to the value recorded during the first assessment.	From enrollment to the date of surgery

次要结果测量

结果测量	措施说明	大体时间
Increased thickness of the quadriceps femoris muscle 大体时间：From enrollment to the date of surgery	An increase in the thickness of the quadriceps femoris muscle will be assessed via ultrasound as a direct sign of an increase in the number and volume of muscle fibres	From enrollment to the date of surgery
Increased cross-sectional area of the quadriceps femoris muscle 大体时间：From enrollment to the date of surgery	An increase in the cross-sectional area of the quadriceps femoris muscle will be assessed via ultrasound as a direct sign of an increase in the number and volume of muscle fibres	From enrollment to the date of surgery
Increased pennation angle of the quadriceps femoris muscle 大体时间：From enrollment to the date of surgery	An increase in the pennation angle of the quadriceps femoris muscle, assessed by ultrasound, is a direct sign of increased contractility of the muscle itself, and therefore an indirect index of an increase in muscle strength.	From enrollment to the date of surgery
Change in Pulmonary Function Parameters 大体时间：From enrollment to the date of surgery	Change in pulmonary volumes including Forced Expiratory Volume in 1 second (FEV1), Forced Vital Capacity (FVC), and Tiffeneau Index (FEV1/FVC ratio) measured through spirometry at baseline and after completion of prehabilitation.	From enrollment to the date of surgery
Improvement in Functional Performance Tests 大体时间：From enrollment to the date of surgery	Change in performance at Handgrip Strength test (Newton), and Maximal Isometric Strength test (Newton), assessed at baseline and after the prehabilitation program. An increase in the value indicates an improvement in functional capacity.	From enrollment to the date of surgery
Change in Diaphragmatic Excursion 大体时间：From enrollment to the date of surgery	Variation in diaphragmatic movement amplitude assessed by ultrasound before and after the prehabilitation period.	From enrollment to the date of surgery
Change in Health-Related Quality of Life (EQ-5D-5L Index) 大体时间：From enrollment to 180 days after discharge	Variation in patient-reported quality of life as assessed by the EQ-5D-5L questionnaire. The index score will be compared between baseline and preoperative assessment after prehabilitation and also at 30 days and 180days after discharge	From enrollment to 180 days after discharge
Incidence of Postoperative Delirium in the Intensive Care Unit 大体时间：Perioperative/Periprocedural	Occurrence of postoperative delirium evaluated daily during ICU stay using the Confusion Assessment Method for the ICU (CAM-ICU).	Perioperative/Periprocedural
Change in Nutritional and Biochemical Markers 大体时间：From enrollment to 30 days after discharge	Variation in nutritional status indicators assessed through blood biochemical parameters (albumin, prealbumin, total protein, lymphocyte count, iron, transferrin, vitamin B12, folic acid, hemoglobin,) before the prehabilitation program, after the prehabilitation program and at 30 days after discharge	From enrollment to 30 days after discharge
Length of Stay in Intensive Care Unit 大体时间：Perioperative/Periprocedural	Duration of ICU stay (in days) from postoperative admission to ICU discharge.	Perioperative/Periprocedural
Total Hospital Length of Stay 大体时间：Perioperative/Periprocedural	Total duration of hospitalization (in days) from admission for surgery to hospital discharge.	Perioperative/Periprocedural
180-Day Mortality 大体时间：From discharge to 180 days after surgery	All-cause mortality evaluated at 180 days after surgery.	From discharge to 180 days after surgery

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

ASST Sette Laghi

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年7月29日

初级完成 (估计的)

2028年7月31日

研究完成 (估计的)

2028年11月30日

研究注册日期

首次提交

2026年2月18日

首先提交符合 QC 标准的

2026年9月25日

首次发布 (实际的)

2026年10月1日

研究记录更新

最后更新发布 (实际的)