The Second Hospital of Shandong University
Jinan, Shandong, 250033, China
NCT Number: NCT06578611
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.
Trial opening soon.
Get Notified65 year and older
All sexes
Observational
Jinan, Shandong, 250033, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Recommended pre-, intra-, and post-operative care interventions in the enhanced recovery after surgery.
Time frame: 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.
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.
The period from admission to discharge 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.
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.
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.
Quality of life after surgery will be evaluated using EuroQol-5-Dimensions-5-Level.
Contact information is provided by the study sponsor or research team.
The Second Hospital of Shandong University
Other
The Effects of Perioperative Smoking Cessation on Complications in Elderly Chinese Undergoing Spinal Fusion With Enhanced Recovery After Surgery: A Prospective Cohort Study
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