Perioperative Smoking Cessation in Elderly Chinese Undergoing Spinal Fusion

NCT ID: NCT06578611

Last Updated: 2024-08-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 2000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2027-12-31

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.

Conditions

Spinal Fusion

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Non-smokers

Patients who did not smoke at recruitment and during follow-up.

No interventions assigned to this group

Continuous smokers

Patients who smoked at recruitment and during follow-up.

Enhanced recovery after surgery

Intervention Type: COMBINATION_PRODUCT

Recommended pre-, intra-, and post-operative care interventions in the enhanced recovery after surgery.

Smoking quitters

Patients who smoked at recruitment but quitted during follow-up.

Enhanced recovery after surgery

Intervention Type: COMBINATION_PRODUCT

Recommended pre-, intra-, and post-operative care interventions in the enhanced recovery after surgery.

Interventions

Enhanced recovery after surgery

Recommended pre-, intra-, and post-operative care interventions in the enhanced recovery after surgery.

Intervention Type: COMBINATION_PRODUCT

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Second Hospital of Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Second Hospital of Shandong University

Jinan, Shandong, China

Countries

China

Central Contacts

Shiqing Feng, MD

Role: CONTACT

shiqingfeng@sdu.edu.cn

86-13920286292

Facility Contacts

Shiqing Feng, MD

Role: primary

shiqingfeng@sdu.edu.cn

Other Identifiers

2024 Elderly Spinal Fusion

Identifier Type: -

Identifier Source: org_study_id