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

Completed

• Conditions: Lumbar Spinal Fusion; Early Discharge; Readmission
• Interventions: Behavioral: Rates of readmission and reoperation

• Registration Number: NCT04126980
• Lead Sponsor: Taipei Veterans General Hospital, Taiwan

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.

Study Timeline

• Study Start: 2018-09-11
• Primary Completion: 2019-09-03
• Study Completion: 2019-09-03
• Study First Submitted: 2019-09-22
• Status Verified: 2019-10
• Study First Submitted QC: 2019-10-14
• Study First Posted: 2019-10-15
• Last Update Submitted: 2019-10-15
• Last Update Posted: 2019-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18008

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ED group	Rates of readmission and reoperation	The ED group who had less than 72 hours of hospitalization (including the preparation period which commonly took approximately 1 day) for the surgery.
Comparison group	Rates of readmission and reoperation	The comparison group who were hospitalized for more than 72 hours but less than 12 days.

Primary Outcome Measures

Name	Time	Method
Demographic characteristics	2011-2013	The comparison group and the ED group had some differences in gender composition, age, and medical comorbidities.

Trial Locations

Locations (1)

Taipei Veterans General Hospital; 🇨🇳 Taipei county, Taiwan