Perioperative Smoking Cessation in Elderly Chinese Undergoing Spinal Fusion

The Second Hospital of Shandong University

Status: Not yet enrolling

Conditions: Spinal Fusion

Treatments: Combination Product: Enhanced recovery after surgery

Study type: Observational

Funder types: Other

Identifiers

NCT06578611

2024 Elderly Spinal Fusion

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

2,000 participants in 3 patient groups

Non-smokers

Description:

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

Continuous smokers

Description:

Patients who smoked at recruitment and during follow-up.

Treatment:

Combination Product: Enhanced recovery after surgery

Smoking quitters

Description:

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

Treatment:

Combination Product: Enhanced recovery after surgery