Perioperative Smoking Cessation in Elderly Chinese Undergoing Spinal Fusion

August 28, 2024 updated by: The Second Hospital of Shandong University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250033

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients aged 65 years old or more undergoing spinal fusion.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.
Combination product: Enhanced recovery after surgery
Recommended pre-, intra-, and post-operative care interventions in the enhanced recovery after surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From the date of surgery until 6 months after surgery or the date of death from any cause, whichever come first.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
The period from admission to discharge will be reported.
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 postoperative pain will be assessed using the numeric rating scale.
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.
Pain-related disability will be assessed using Oswestry Disability Index (ODI).
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.
Quality of life after surgery will be evaluated using EuroQol-5-Dimensions-5-Level.
From the date of surgery until 6 months after surgery or the date of death from any cause, whichever come first.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Second Hospital of Shandong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

August 27, 2024

First Submitted That Met QC Criteria

August 28, 2024

First Posted (Actual)

August 29, 2024

Study Record Updates

Last Update Posted (Actual)

August 29, 2024

Last Update Submitted That Met QC Criteria

August 28, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 2024 Elderly Spinal Fusion

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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