Perioperative Smoking Cessation in Elderly Chinese Undergoing Spinal Fusion

NCT06578611 | Not Yet Recruiting

• 1 other identifier: 2024 Elderly Spinal Fusion
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Fusion

Outcome Measures

Primary Outcomes (1)

• Incidence of any complications

  Any major or minor complications occurs during this study will be reported.

  From the date of surgery until 6 months after surgery or the date of death from any cause, whichever come first.

Secondary Outcomes (4)

• 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.

• 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 pain-related disability

  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

  From the date of surgery until 6 months after surgery or the date of death from any cause, whichever come first.

Study Arms (3)

Non-smokers

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

Continuous smokers

Patients who smoked at recruitment and during follow-up.

Combination Product: Enhanced recovery after surgery

Smoking quitters

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

Combination Product: Enhanced recovery after surgery

Interventions

Enhanced recovery after surgery COMBINATION_PRODUCT

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

Continuous smokers; Smoking quitters

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged 65 years old or more undergoing spinal fusion.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Second Hospital of Shandong University: lead

Study Sites (1)

The Second Hospital of Shandong University

Jinan, Shandong, 250033, China

Location

Biospecimen

Blood samples will be collected after admission for assessment of biomarkers.

MeSH Terms

Interventions

Enhanced Recovery After Surgery

Intervention Hierarchy (Ancestors)

Perioperative Care; Surgical Procedures, Operative

Central Study Contacts

Shiqing Feng, MD

CONTACT

86-13920286292; shiqingfeng@sdu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: August 29, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 29, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)