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Not Yet RecruitingNCT06578611

Perioperative Smoking Cessation in Elderly Chinese Undergoing Spinal Fusion

The Effects of Perioperative Smoking Cessation on Complications in Elderly Chinese Undergoing Spinal Fusion With Enhanced Recovery After Surgery: A Prospective Cohort Study

Status
Not Yet Recruiting
Phase
Study type
Observational
Enrollment
2,000 (estimated)
Sponsor
The Second Hospital of Shandong University · Academic / Other
Sex
All
Age
65 Years
Healthy volunteers
Not accepted

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

Interventions

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

Timeline

Start date
2024-09-01
Primary completion
2026-12-01
Completion
2027-12-01
First posted
2024-08-29
Last updated
2024-08-29

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT06578611. Inclusion in this directory is not an endorsement.