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

2026년 9월 25일 업데이트: 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.

연구 개요

상태

모병

정황

연구 유형

관찰

등록 (추정된)

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

이름: Massimo Stella, MD
전화번호: 0039 0332393447
이메일: maxstella95@gmail.com

연구 장소

이탈리아
- - Varese, 이탈리아, 21100
    - 모집하지 않고 적극적으로
    - ASST Sette Laghi
- VA
  - Varese, VA, 이탈리아, 21052
    - 모병
    - Ospedale di Circolo
    - 연락하다:
      
      Massimo Stella, MD
      
      전화번호: +39 0332 393447
      
      이메일: maxstella95@gmail.com

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

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.

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

관찰 모델: CASE_ONLY
시간 관점: PROSPECTIVE

그룹/코호트 수

코호트 및 개입

그룹/코호트
Eligible patients for major surgery

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정	측정값 설명	기간
10% improvement from baseline at 6-minutes-walking-test-distance 기간: 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

2차 결과 측정

결과 측정	측정값 설명	기간
Increased thickness of the quadriceps femoris muscle 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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) 기간: 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 기간: 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 기간: 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 기간: Perioperative/Periprocedural	Duration of ICU stay (in days) from postoperative admission to ICU discharge.	Perioperative/Periprocedural
Total Hospital Length of Stay 기간: Perioperative/Periprocedural	Total duration of hospitalization (in days) from admission for surgery to hospital discharge.	Perioperative/Periprocedural
180-Day Mortality 기간: From discharge to 180 days after surgery	All-cause mortality evaluated at 180 days after surgery.	From discharge to 180 days after surgery

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

ASST Sette Laghi

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 7월 29일

기본 완료 (추정된)

2028년 7월 31일

연구 완료 (추정된)

2028년 11월 30일

연구 등록 날짜

최초 제출

2026년 2월 18일

QC 기준을 충족하는 최초 제출

2026년 9월 25일

처음 게시됨 (실제)

2026년 10월 1일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)