Spinal FusionNCT06578611
Perioperative Smoking Cessation in Elderly Chinese Undergoing Spinal Fusion
An observational study of Spinal Fusion, run by The Second Hospital of Shandong University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Spinal Fusion
- What is being tested?
- Enhanced recovery after surgery
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- Sep 2024to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients aged 65 years old or more undergoing spinal fusion.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Second Hospital of Shandong University
Jinan, Shandong, 250033
Shiqing Feng, MD, shiqingfeng@sdu.edu.cn
About this study
Official title: The Effects of Perioperative Smoking Cessation on Complications in Elderly Chinese Undergoing Spinal Fusion With Enhanced Recovery After Surgery: A Prospective Cohort Study
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.
Read the 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
- Being tested
- Enhanced recovery after surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced recovery after surgeryCombination product
Recommended pre-, intra-, and post-operative care interventions in the enhanced recovery after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Non-smokers | Patients who did not smoke at recruitment and during follow-up. | |
| Continuous smokers | Patients who smoked at recruitment and during follow-up. Receives: Combination Product: Enhanced recovery after surgery | |
| Smoking quitters | Patients who smoked at recruitment but quitted during follow-up. Receives: Combination Product: Enhanced recovery after surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of any complications
Any major or minor complications occurs during this study will be reported.
Measured: 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
The period from admission to discharge will be reported.
Measured: 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
Prevalence of postoperative pain will be assessed using the numeric rating scale.
Measured: 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
Pain-related disability will be assessed using Oswestry Disability Index (ODI).
Measured: 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
Quality of life after surgery will be evaluated using EuroQol-5-Dimensions-5-Level.
Measured: From the date of surgery until 6 months after surgery or the date of death from any cause, whichever come first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study startSep 2024 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal FusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06578611
- Sponsor's protocol ID
- 2024 Elderly Spinal Fusion
- Status last verified
- Aug 2024
- First submitted
- 27 Aug 2024
- Last updated
- 29 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Perioperative Smoking Cessation on Complications in Elderly Chinese Undergoing Spinal Fusion With Enhanced Recovery After Surgery: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06578611
- Acronym / sponsor ID
- 2024 Elderly Spinal Fusion
- Conditions
- Spinal Fusion
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- The Second Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 29 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non-smokers | – | –Patients who did not smoke at recruitment and during follow-up. |
| Continuous smokers | – | Combination Product: Enhanced recovery after surgeryPatients who smoked at recruitment and during follow-up. |
| Smoking quitters | – | Combination Product: Enhanced recovery after surgeryPatients who smoked at recruitment but quitted during follow-up. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients aged 65 years old or more undergoing spinal fusion.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced recovery after surgeryRecommended pre-, intra-, and post-operative care interventions in the enhanced recovery after surgery. | Combination product | Continuous smokers, Smoking quitters |
Primary outcome
Incidence of any complications
Time frame: 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.
4 secondary outcomes
Length of hospital stay
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From the date of surgery until 6 months after surgery or the date of death from any cause, whichever come first.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Fusion, run by The Second Hospital of Shandong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shiqing Feng, MD (86-13920286292, shiqingfeng@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of any complications (time frame: From the date of surgery until 6 months after surgery or the date of death from any cause, whichever come first.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2024.