Clinical Trials Directory

Trials / Completed

CompletedNCT04126980

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

Status
Completed
Phase
Study type
Observational
Enrollment
18,008 (actual)
Sponsor
Taipei Veterans General Hospital, Taiwan · Other Government
Sex
All
Age
50 Years – 70 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALRates of readmission and reoperationAll 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.

Timeline

Start date
2018-09-11
Primary completion
2019-09-03
Completion
2019-09-03
First posted
2019-10-15
Last updated
2019-10-17

Locations

1 site across 1 country: Taiwan

Source: ClinicalTrials.gov record NCT04126980. Inclusion in this directory is not an endorsement.