NCT04012528

Brief Summary

The aim of this study is to compare the outcomes after scoliosis surgery before and after ERAS (enhanced recovery after surgery) program inplementation in children and teenager.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 26, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 9, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
Last Updated

December 29, 2020

Status Verified

December 1, 2020

Enrollment Period

2.8 years

First QC Date

April 26, 2019

Last Update Submit

December 28, 2020

Conditions

Scoliosis

Keywords

PediatricSurgeryRehabilitation

Outcome Measures

Primary Outcomes (1)

  • Postoperative length of hospital stay

    Postoperative length of hospital stay

    up to 4 weeks after surgery

Secondary Outcomes (4)

  • Number of Antalgics consumption

    up to 15 days after surgery

  • Time to oral diet tolerance

    up to 15 days after surgery

  • Time to first bowel motion

    up to 15 days after surgery

  • Time to first verticalization

    up to 15 days after surgery

Study Arms (2)

"the before" group

75 teenagers after scoliosis surgery before ERAS program implementation

Other: ERAS program

"the after" group

75 teenagers after scoliosis surgery after ERAS program implementation

Interventions

ERAS programOTHER

ERAS program

"the before" group

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Chidren and teenager admitted for scoliosis surgery

You may qualify if:

  • patient with age \< 18 years
  • patient scheduled for scoliosis surgery

You may not qualify if:

  • patient with age \> 18years
  • patient with medical follow up by pediatric chronic pain departement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uh Montpellier

Montpellier, 34925, France

Location

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Chrystelle CS SOLA, MD

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 26, 2019

First Posted

July 9, 2019

Study Start

January 1, 2018

Primary Completion

November 1, 2020

Study Completion

November 30, 2021

Last Updated

December 29, 2020

Record last verified: 2020-12

Locations

FR(1)