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NCT Number: NCT06578611

Perioperative Smoking Cessation in Elderly Chinese Undergoing Spinal Fusion

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.

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Key information

Conditions

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Second Hospital of Shandong University

Jinan, Shandong, 250033, China

Location contact

Shiqing Feng, MD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Enhanced recovery after surgery

Combination Product

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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).

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Shiqing Feng, MD

CONTACT

[email protected]

86-13920286292

Sponsors and collaborators

Lead sponsor

The Second Hospital of Shandong University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Aug 29, 2024
Registry last updated
Aug 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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