ERAS and Pediatric Scoliosis Surgery (RAAC)

December 28, 2020 updated by: University Hospital, Montpellier

Assesment of Enhanced Recovery After Pediatric Idiopathic Scoliosis Surgery

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Montpellier, France, 34925
        • UH Montpellier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Chidren and teenager admitted for scoliosis surgery

Description

Inclusion criteria:

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

Exclusion criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
"the before" group
75 teenagers after scoliosis surgery before ERAS program implementation
ERAS program
"the after" group
75 teenagers after scoliosis surgery after ERAS program implementation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative length of hospital stay
Time Frame: up to 4 weeks after surgery
Postoperative length of hospital stay
up to 4 weeks after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Antalgics consumption
Time Frame: up to 15 days after surgery
Antalgics consumption including opioids and non-opioids drug
up to 15 days after surgery
Time to oral diet tolerance
Time Frame: up to 15 days after surgery
Able to eat without abdominal discomfort, nausea, or vomiting
up to 15 days after surgery
Time to first bowel motion
Time Frame: up to 15 days after surgery
Able to eat without abdominal discomfort, nausea, or vomiting
up to 15 days after surgery
Time to first verticalization
Time Frame: up to 15 days after surgery
Able to eat without abdominal discomfort, nausea, or vomiting
up to 15 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Chrystelle CS SOLA, MD, University Hospital, Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

November 1, 2020

Study Completion (Anticipated)

November 30, 2021

Study Registration Dates

First Submitted

April 26, 2019

First Submitted That Met QC Criteria

July 5, 2019

First Posted (Actual)

July 9, 2019

Study Record Updates

Last Update Posted (Actual)

December 29, 2020

Last Update Submitted That Met QC Criteria

December 28, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • RECHMPL18_0382

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

NC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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