Clinical trial

Prehabilitation Combined With Enhanced Recovery After Surgery (PREERAS) in the Chinese Elderly With Spine Surgery

Name
lushibao
Description
With the extended life expectancy of the Chinese population and improvements in surgery and anesthesia techniques, the number of aged patients undergoing surgery has been increasing annually. However, safety, effectiveness, and quality of life of aged patients undergoing surgery are facing major challenges. This prospective, multi-center, randomized, controlled study aims to construct a prehabilitation combined with enhanced recovery after surgery program which includes pre-operative risk assessment and targeted intervention.
Trial arms
Trial start
2024-04-15
Estimated PCD
2025-12-30
Trial end
2026-12-01
Status
Recruiting
Treatment
Multimodal prehabilitation combined with perioperative ERAS care(PREERAS)
Pre-admission risk assessment and targeted intervention provided by multidisciplinary team
Arms:
PREERAS group
Size
164
Primary endpoint
Comprehensive Complication Index
up to 90 days after surgery
Eligibility criteria
Inclusion Criteria: 1. patients who voluntarily sign the informed consent form; (2) elective spinal fusion surgery for degenerative spinal disorders; (3) no severe cognitive impairment (MoCA score ≥ 8). Exclusion Criteria: Patients (1) are scheduled to undergo emergency or day surgery, 2. have urgent condition that needs to be managed before the surgery, 3. are unable to cooperate with preoperative assessment, 4. have spinal fractures, metastasis, and spinal infections, 5. unable to understand or participate safely in intervention program, 6. participate in another study that may affect the study.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 164, 'type': 'ESTIMATED'}}
Updated at
2024-05-01

1 organization

1 product

3 indications

Organization
Xuanwu Hospital
Product
PREERAS
Indication
Spinal Fusion
Indication
Frailty