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

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ClinicalTrials.gov Identifier: NCT04126980
Recruitment Status : Completed
First Posted : October 15, 2019
Last Update Posted : October 17, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Lumbar Spinal Fusion Early Discharge Readmission Behavioral: Rates of readmission and reoperation

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.

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Study Type : Observational
Actual Enrollment : 18008 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Early Discharged Lumbar Spine Fusion Reduced Postoperative Readmissions: A Follow-up Study in a National Cohort
Actual Study Start Date : September 11, 2018
Actual Primary Completion Date : September 3, 2019
Actual Study Completion Date : September 3, 2019

Group/Cohort Intervention/treatment
ED group
The ED group who had less than 72 hours of hospitalization (including the preparation period which commonly took approximately 1 day) for the surgery.
Behavioral: Rates of readmission and reoperation
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.

Comparison group
The comparison group who were hospitalized for more than 72 hours but less than 12 days.
Behavioral: Rates of readmission and reoperation
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 Outcome Measures :
  1. Demographic characteristics [ Time Frame: 2011-2013 ]
    The comparison group and the ED group had some differences in gender composition, age, and medical comorbidities.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04126980


Locations
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Taiwan
Taipei Veterans General Hospital
Taipei county, Taiwan, 112
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
Investigators
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Study Director: Taipei Veterans General Hospital Taipei Veterans General Hospital, Taiwan

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Responsible Party: Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier: NCT04126980    
Other Study ID Numbers: 2018-09-0006CC
First Posted: October 15, 2019    Key Record Dates
Last Update Posted: October 17, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No