Clinical trial NCT06578611: Perioperative Smoking Cessation in Elderly Chinese Undergoing Spinal Fusion
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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Spinal Fusion
Lead sponsor: The Second Hospital of Shandong University
Sponsor class: OTHER
First posted: 2024-08-29
Enrollment: 2000
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 65 years old or more undergoing spinal fusion.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of any complications
timeFrame: From the date of surgery until 6 months after surgery or the date of death from any cause, whichever come first.
Secondary outcomes:
measure: Length of hospital stay
timeFrame: 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.
measure: Prevalence of postoperative pain
timeFrame: From the date of surgery until 6 months after surgery or the date of death from any cause, whichever come first.
measure: Prevalence of pain-related disability
timeFrame: From the date of surgery until 6 months after surgery or the date of death from any cause, whichever come first.
measure: Level of quality of life
timeFrame: From the date of surgery until 6 months after surgery or the date of death from any cause, whichever come first.
Other outcomes:
Locations:
city: Jinan
country: China
facility: The Second Hospital of Shandong University
state: Shandong
Study officials:
References: