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Status unknownNCT04012528RAACUpdated Dec 29, 2020

ERAS and Pediatric Scoliosis Surgery

An observational study in Scoliosis, sponsored by University Hospital, Montpellier. Status unknown at 1 site in France. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2020-12-29.

Sponsored by University Hospital, Montpellier · Observational

The sponsor has not verified this record recently (last verified Dec 2020), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
150
Ages
Up to 18 Years
Sex
All
01

Study 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.

Read the detailed description

Enhanced recovery after surgery (ERAS) is a multimodal approach focused on reducing the stress response and associated physiologic changes related to surgery. Over the past 20 years, ERAS programs have been found to result in reduced lenght of stay and complications in adult patients. Data in pediatric population remains very scarce.Therefore this study was designed to compare the outcomes after scoliosis surgery before and after ERAS (enhanced recovery after surgery) program inplementation in children and teenager.

02

Conditions studied

  • Scoliosis

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Keywords

  • Pediatric
  • Surgery
  • Rehabilitation
03

In context

Scoliosis

594 studies on the registry are indexed under Scoliosis; 139 are open to participants now.

This study's planned enrollment of 150 is above the median of 89 across 233 observational studies indexed under Scoliosis.

Browse Scoliosis studies →

Lead sponsor

University Hospital, Montpellier is the lead sponsor of 1,244 studies on the registry; 225 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Chidren and teenager admitted for scoliosis surgery

Inclusion criteria

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

Exclusion criteria

Exclusion criteria:

  • patient with age > 18years
  • patient with medical follow up by pediatric chronic pain departement
05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
150 participants (estimated)
Patient registry
No

Groups and cohorts

  • "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

  • OtherERAS program

    ERAS program

06

What researchers measure

Primary outcomes

  1. Postoperative length of hospital stay

    Postoperative length of hospital stay

    Time frame: up to 4 weeks after surgery

Secondary outcomes

  1. Number of Antalgics consumption

    Antalgics consumption including opioids and non-opioids drug

    Time frame: up to 15 days after surgery

  2. Time to oral diet tolerance

    Able to eat without abdominal discomfort, nausea, or vomiting

    Time frame: up to 15 days after surgery

  3. Time to first bowel motion

    Able to eat without abdominal discomfort, nausea, or vomiting

    Time frame: up to 15 days after surgery

  4. Time to first verticalization

    Able to eat without abdominal discomfort, nausea, or vomiting

    Time frame: up to 15 days after surgery

07

Study locations

1 site
  • Uh Montpellier
    Montpellier, 34925, France
08

References and documents

Individual participant data

Plan to share: Undecided — NC

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 29, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04012528
Lead sponsor
University Hospital, Montpellier
Responsible party
Sponsor
First posted
Jul 9, 2019
Start date
Jan 1, 2018
Primary completion
Nov 1, 2020
Completion
Nov 30, 2021 (estimated)
Last update
Dec 29, 2020

Study contacts

Chrystelle CS SOLA, MD
principal investigator · University Hospital, Montpellier

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.

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