Spinal Fusion
Conditions
Brief summary
As China's society ages faster, the number of elderly patients undergoing spinal fusion surgery will gradually increase. Since elderly patients are at higher risk of postoperative complications than younger patients, minimizing complications after spinal fusion becomes a priority in postoperative rehabilitation. The purpose of this prospective cohort study is to develop an enhanced recovery after surgery program including individualized perioperative smoking cessation strategies in Chinese elderly undergoing spinal fusion.
Detailed description
With the aging society, elderly population in China has reached 172 million (12%) in 2020 and is predicted to rise to 336 million (26%) by 2050. This will be accompanied by more elderly people with degenerative spinal diseases who may become candidates for spinal surgery (e.g., spinal fusion). Compared with younger patients, elderly patients are more likely to experience complications after spinal fusion (e.g., 9% and 14% for \<65 and ≥ 65 years old in lumbar fusion), which may lead to adverse patient outcomes including worse functional outcomes and satisfaction and increased revision surgery. Recently, enhanced recovery after surgery (ERAS) program for spinal fusion including the pre-, intra-, and post-operative care interventions has been developed. Previous studies have shown that ERAS has multiple benefits for elderly undergoing spinal fusion, such as reduced complications and shorter hospital stays. However, the preoperative smoking cessation protocols varied widely between studies (e.g., at least 4 weeks, 3 months, and 2 weeks before surgery), which may be due to a lack of evidence. Therefore, we plan to conduct a prospective study to improve the perioperative smoking cessation strategy of ERAS and establish an evidence-derived protocol.
Interventions
COMBINATION_PRODUCTEnhanced recovery after surgery
Recommended pre-, intra-, and post-operative care interventions in the enhanced recovery after surgery.
Sponsors
The Second Hospital of Shandong University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients aged 65 years old or more; 2. Patients who plan to undergo spinal fusion with ERAS program; 3. Patients who agreed to participate in this study.
Exclusion criteria
1. Patients who cannot understand the study content or have difficulty communicating; 2. Patients with a history of spinal fusion surgery; 3. Patients with spinal fractures, spinal tumor, or spinal infections; 4. Patients with congenital spinal deformity; 5. Patients who were unable to complete at least 6 months of follow-up; 6. Patients with incomplete clinical information.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of any complications | From the date of surgery until 6 months after surgery or the date of death from any cause, whichever come first. | Any major or minor complications occurs during this study will be reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of hospital stay | From the date of admission until the date of discharge or the date of death from any cause, whichever come first, assessed up to 6 months. | The period from admission to discharge will be reported. |
| Prevalence of postoperative pain | From the date of surgery until 6 months after surgery or the date of death from any cause, whichever come first. | Prevalence of postoperative pain will be assessed using the numeric rating scale. |
| Prevalence of pain-related disability | From the date of surgery until 6 months after surgery or the date of death from any cause, whichever come first. | Pain-related disability will be assessed using Oswestry Disability Index (ODI). |
| Level of quality of life | From the date of surgery until 6 months after surgery or the date of death from any cause, whichever come first. | Quality of life after surgery will be evaluated using EuroQol-5-Dimensions-5-Level. |
Countries
China
Contacts
Primary ContactShiqing Feng, MD
Outcome results
None listed