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NCT04012528 Clinical Trial

ERAS and Pediatric Scoliosis Surgery

Scoliosis Clinical Trial

— RAAC  

Official title:
Assesment of Enhanced Recovery After Pediatric Idiopathic Scoliosis Surgery

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04012528
Other study ID # RECHMPL18_0382
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 1, 2018
Est. completion date November 30, 2021

Study information
Verified date December 2020
Source University Hospital, Montpellier
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 150
Est. completion date November 30, 2021
Est. primary completion date November 1, 2020
Accepts healthy volunteers No
Gender All
Age group N/A to 18 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• ERAS program
ERAS program

Locations
Country Name City State
France Uh Montpellier Montpellier

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Postoperative length of hospital stay Postoperative length of hospital stay up to 4 weeks after surgery
Secondary Number of Antalgics consumption Antalgics consumption including opioids and non-opioids drug up to 15 days after surgery
Secondary Time to oral diet tolerance Able to eat without abdominal discomfort, nausea, or vomiting up to 15 days after surgery
Secondary Time to first bowel motion Able to eat without abdominal discomfort, nausea, or vomiting up to 15 days after surgery
Secondary Time to first verticalization Able to eat without abdominal discomfort, nausea, or vomiting up to 15 days after surgery
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