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Completed

NCT Number: NCT04126980

Early Discharged Lumbar Spine Fusion Reduced Postoperative Readmissions: A Follow-up Study in a National Cohort

This study undertake to determine the effects of ED on readmissions and reoperations in lumbar fusion. The study enrolled patients who underwent lumbar fusion surgery at age 50-70 years from a national database, and grouped them into an ED group or a comparison group. All patients were then followed-up for 180 days after the indexed surgery of lumbar fusion.

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Key information

Conditions

Lumbar Spinal Fusion Early Discharge Readmission

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Taipei Veterans General Hospital

Taipei County, 112, Taiwan

About this study

Surgery for lumbar fusion is one of the most commonly performed spinal arthrodesis procedures worldwide. In recent years, there has been the emerging popularity of strategies aimed at early discharge (ED) in such a field of spinal surgery. However, more data are required to corroborate the adaptation of ED in spinal surgery. The benefits of ED in lumbar fusion have not yet been validated by large cohort studies. This study undertake to determine the effects of ED on readmissions and reoperations in lumbar fusion.

This population-based retrospective cohort study used admission records of Taiwan's National Health Insurance Research Database (NHIRD). The NHIRD comprehensively contains de-identified claim data of Taiwan's National Health Insurance (NHI) program which covers 99% of the Taiwanese population and contracts with 97% of the providers of healthcare services in Taiwan. In order to protect privacy, the National Health Research Institute (NHRI) re-compiled, validated and de-identified the medical claims and finally made the data publicly available for medical researchers in Taiwan. In the admission database, the investigators are able to trace comprehensive information on the insured subjects, including gender, date of birth, dates of clinical visits and hospitalization, the International Classification of Diseases (Ninth Revision) Clinical Modification (ICD-9-CM) codes of diagnoses, ICD codes of surgical procedures, etc.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients who underwent lumbar spinal fusion surgery between July 2011 and June 2013 were identified and extracted in the NHIRD.

Exclusion criteria

  • Inconsistent conditions

Treatment and study plan

Rates of readmission and reoperation

Behavioral

All patients were then followed-up for 180 days after the indexed surgery of lumbar fusion. All-causes of re-hospitalization and re-operations for lumbar spine fusion, were analyzed at 30, 60 and 180 days for comparison between the ED group and the comparison group.

Primary outcomes

  1. Demographic characteristics

    Time frame: 2011-2013

    The comparison group and the ED group had some differences in gender composition, age, and medical comorbidities.

Sponsors and collaborators

Lead sponsor

Taipei Veterans General Hospital, Taiwan

Other Gov

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 15, 2019
Registry last updated
Oct 17, 2019

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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