Health TrialsbyHealthPanel

Perioperative Smoking Cessation in Elderly Chinese Undergoing Spinal Fusion

ConditionSpinal Fusion
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorThe Second Hospital of Shandong University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial population

Patients aged 65 years old or more undergoing spinal fusion.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Enhanced recovery after surgery

    Combination product

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

Treatment groups

2,000 Participants
are divided into 3 treatment groups
Group A: Non-smokers0 interventions
Group B: Continuous smokers1 intervention
Group C: Smoking quitters1 intervention

Trial outcomes

Primary outcomes

1

Incidence of any complications

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

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

Secondary outcomes

1

Length of hospital stay

The period from admission to discharge will be reported.

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.
2

Prevalence of postoperative pain

Prevalence of postoperative pain will be assessed using the numeric rating scale.

Time frame
From the date of surgery until 6 months after surgery or the date of death from any cause, whichever come first.
3

Prevalence of pain-related disability

Pain-related disability will be assessed using Oswestry Disability Index (ODI).

Time frame
From the date of surgery until 6 months after surgery or the date of death from any cause, whichever come first.
4

Level of quality of life

Quality of life after surgery will be evaluated using EuroQol-5-Dimensions-5-Level.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Second Hospital of Shandong University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: