Pre-operative risk assessment and intervention for elderly spine surgery patients in China
Prehabilitation Combined With Enhanced Recovery After Surgery (PREERAS) in the Chinese Elderly With Spine Surgery
This study is testing a program to help older patients get ready for spine surgery in China to see if it makes their recovery safer and faster.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 164 (estimated) |
| Ages | 75 Years and up |
| Sex | All |
| Sponsor | Xuanwu Hospital, Beijing Academic / other |
| Locations | 3 sites (Beijing, Beijing and 2 other locations) |
| Trial ID | NCT06140797 on ClinicalTrials.gov |
What this trial studies
This study aims to improve the safety and effectiveness of spine surgery in elderly patients by implementing a prehabilitation program combined with enhanced recovery after surgery (ERAS) protocols. It focuses on conducting pre-operative risk assessments and targeted interventions to address common issues such as malnutrition and decreased functional capacity in older adults. The study will be conducted across multiple centers in Beijing, involving patients undergoing elective spinal fusion surgery for degenerative conditions. By optimizing the care of elderly patients before surgery, the study seeks to enhance postoperative recovery and overall quality of life.
Who should consider this trial
Good fit: Ideal candidates are elderly patients scheduled for elective spinal fusion surgery who do not have severe cognitive impairment.
Not a fit: Patients requiring emergency surgery or those with conditions that prevent safe participation in the intervention will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve recovery outcomes and quality of life for elderly patients undergoing spine surgery.
How similar studies have performed: Other studies have shown promising results with enhanced recovery protocols in surgical patients, but this specific approach for elderly spine surgery is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing, Beijing and 2 other locations
- Peking University First Hospital — Beijing, Beijing, China (Recruiting)
- Beijing Friendship Hospital, Capital Medical University — Beijing, Beijing, China (Recruiting)
- Xuanwu Hospital, Capital Medical University — Beijing, Beijing, China (Recruiting)
Study contacts
- Principal investigator: Chun-De Li — Peking University First Hospital
- Study coordinator: Shibao Lu, MD
- Email: 445119837@qq.com
- Phone: +8615804084262
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.