Perioperative Smoking Cessation in Elderly Chinese Undergoing Spinal Fusion

Not yet recruiting

• Conditions: Spinal Fusion
• Interventions: Combination Product: Enhanced recovery after surgery

• Registration Number: NCT06578611
• Lead Sponsor: The Second Hospital of Shandong University

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.

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-27
• Study First Submitted QC: 2024-08-28
• Last Update Submitted: 2024-08-28
• Study First Posted: 2024-08-29
• Last Update Posted: 2024-08-29
• Study Start: 2024-09
• Primary Completion: 2026-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 2000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Continuous smokers	Enhanced recovery after surgery	Patients who smoked at recruitment and during follow-up.
Smoking quitters	Enhanced recovery after surgery	Patients who smoked at recruitment but quitted during follow-up.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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 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).

Trial Locations

Locations (1)

The Second Hospital of Shandong University; 🇨🇳 Jinan, Shandong, China