NCT04126980

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18,008

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 11, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 3, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 3, 2019

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

September 22, 2019

Completed
23 days until next milestone

First Posted

Study publicly available on registry

October 15, 2019

Completed
Last Updated

October 17, 2019

Status Verified

October 1, 2019

Enrollment Period

12 months

First QC Date

September 22, 2019

Last Update Submit

October 15, 2019

Conditions

Lumbar Spinal FusionEarly DischargeReadmission

Outcome Measures

Primary Outcomes (1)

  • Demographic characteristics

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

    2011-2013

Study Arms (2)

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

Comparison group

The comparison group who were hospitalized for more than 72 hours but less than 12 days.

Behavioral: Rates of readmission and reoperation

Interventions

Rates of readmission and reoperationBEHAVIORAL

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 groupED group

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Inconsistent conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Veterans General Hospital

Taipei County, 112, Taiwan

Location

MeSH Terms

Interventions

Reoperation

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

  • Taipei Veterans General Hospital

    Taipei Veterans General Hospital, Taiwan

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2019

First Posted

October 15, 2019

Study Start

September 11, 2018

Primary Completion

September 3, 2019

Study Completion

September 3, 2019

Last Updated

October 17, 2019

Record last verified: 2019-10

Locations

TW(1)