ERAS and Pediatric Scoliosis Surgery | NCT04012528

Studies
ERAS and Pediatric Scoliosis Surgery

NCT04012528

Sponsor

University Hospital, Montpellier

Status

Unknown status

Last Update Posted

Dec 29, 2020Actual

Enrollment

150Estimated

Phase

Not provided

Conditions

Scoliosis

Interventions

ERAS program

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2018Actual

Primary Completion Date

Nov 1, 2020Actual

Completion Date

Nov 30, 2021Estimated

First Submitted Date

Apr 26, 2019

First Submission Date that Met QC Criteria

Jul 5, 2019

First Posted Date

Jul 9, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 28, 2020

Last Update Posted Date

Dec 29, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
"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

Name	Type	Description	Arm Group Labels	Other Names
ERAS program	Other	ERAS program	"the before" group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Chidren and teenager admitted for scoliosis surgery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Chrystelle CS SOLA, MD	University Hospital, Montpellier	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Uh Montpellier		Montpellier		34925	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012600	Scoliosis

Ancestor Terms

ID	Term
D013121	Spinal Curvatures
D013122	Spinal Diseases
D001847	Bone Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided