Clinical trial NCT04126980: Early Discharged Lumbar Spine Fusion Reduced Postoperative Readmissions: A Follow-up Study in a National Cohort
Official title: Early Discharged Lumbar Spine Fusion Reduced Postoperative Readmissions: A Follow-up Study in a National Cohort
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lumbar Spinal Fusion
Early Discharge
Readmission
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2019-10-15
Enrollment: 18008
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent lumbar spinal fusion surgery between July 2011 and June 2013 were identified and extracted in the NHIRD.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Demographic characteristics
timeFrame: 2011-2013
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei county
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: Taipei Veterans General Hospital, Taiwan
name: Taipei Veterans General Hospital
role: STUDY_DIRECTOR
References: