An observational study in Spinal Fusion, sponsored by The Second Hospital of Shandong University. Not yet recruiting at 1 site in China. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2024-08-29.
Sponsored by The Second Hospital of Shandong University · Observational
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.
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.
The Second Hospital of Shandong University is the lead sponsor of 35 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients aged 65 years old or more undergoing spinal fusion.
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Exclusion Criteria:
Patients who did not smoke at recruitment and during follow-up.
Patients who smoked at recruitment and during follow-up.
Combination Product: Enhanced recovery after surgery
Patients who smoked at recruitment but quitted during follow-up.
Combination Product: Enhanced recovery after surgery
Recommended pre-, intra-, and post-operative care interventions in the enhanced recovery after surgery.
Incidence of any complications
Any major or minor complications occurs during this study will be reported.
Time frame: From the date of surgery until 6 months after surgery or the date of death from any cause, whichever come first.
Length of hospital stay
The period from admission to discharge will be reported.
Time frame: 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.
Prevalence of postoperative pain
Prevalence of postoperative pain will be assessed using the numeric rating scale.
Time frame: From the date of surgery until 6 months after surgery or the date of death from any cause, whichever come first.
Prevalence of pain-related disability
Pain-related disability will be assessed using Oswestry Disability Index (ODI).
Time frame: From the date of surgery until 6 months after surgery or the date of death from any cause, whichever come first.
Level of quality of life
Quality of life after surgery will be evaluated using EuroQol-5-Dimensions-5-Level.
Time frame: From the date of surgery until 6 months after surgery or the date of death from any cause, whichever come first.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2024; primary completion for Dec 2026, 27 months later.
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This study is not yet recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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The Second Hospital of Shandong University