Perioperative Smoking Cessation in Elderly Chinese Undergoing Spinal Fusion
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Enhanced recovery after surgery.
- Who it may be relevant to
- Registry conditions: Spinal Fusion. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effects of Perioperative Smoking Cessation on Complications in Elderly Chinese Undergoing Spinal Fusion With Enhanced Recovery After Surgery: A Prospective Cohort Study
Overview
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 product Enhanced recovery after surgery
Recommended pre-, intra-, and post-operative care interventions in the enhanced recovery after surgery.
Primary outcome measures
- Incidence of any complications [Time frame: From the date of surgery until 6 months after surgery or the date of death from any cause, whichever come first.]
Secondary outcome measures (4)
- Length of hospital stay [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 [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 [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 [Time frame: From the date of surgery until 6 months after surgery or the date of death from any cause, whichever come first.]
Eligibility criteria
Inclusion criteria
- Patients aged 65 years old or more;
- Patients who plan to undergo spinal fusion with ERAS program;
- Patients who agreed to participate in this study.
Exclusion criteria
- Patients who cannot understand the study content or have difficulty communicating;
- Patients with a history of spinal fusion surgery;
- Patients with spinal fractures, spinal tumor, or spinal infections;
- Patients with congenital spinal deformity;
- Patients who were unable to complete at least 6 months of follow-up;
- Patients with incomplete clinical information.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- The Second Hospital of Shandong University — Jinan
Identifiers
NCT: NCT06578611 · 2024 Elderly Spinal Fusion