- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04012528
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
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.
Sponsor
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
Keywords
Additional Relevant MeSH Terms
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.
Clinical Trials on Scoliosis
-
Manhattan Physical Medicine and Rehabilitation,...RecruitingScoliosis Idiopathic | Scoliosis; Adolescence | Scoliosis; Lumbar RegionUnited States
-
Stanford UniversityNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Not yet recruitingScoliosis Idiopathic | Spondylolisthesis | Scoliosis; Adolescence | Kyphosis | Juvenile; Scoliosis | Scoliosis;CongenitalUnited States
-
Seattle Children's HospitalJohns Hopkins University; Duke University; Vanderbilt University; University of... and other collaboratorsRecruitingScoliosis Idiopathic | Spondylolisthesis | Scoliosis; Adolescence | Kyphosis | Juvenile; Scoliosis | Scoliosis;CongenitalUnited States
-
Children's National Research InstituteNational Institute for Biomedical Imaging and Bioengineering (NIBIB); Kitware...RecruitingScoliosis Idiopathic | Scoliosis; JuvenileUnited States
-
Aesculap AGRaylytic GmbHRecruitingIdiopathic Scoliosis | Hyperlordosis | Neuromuscular Scoliosis | Hyperkyphosis | Congenital ScoliosisCzechia
-
Universitat Jaume IRecruitingScoliosis Idiopathic | Scoliosis; Adolescence | BraceSpain
-
Istituto Scientifico Italiano Colonna VertebraleRecruiting
-
Stanford UniversityRecruitingScoliosis; Juvenile | Scoliosis; AdolescenceUnited States
-
Istanbul Gelisim UniversityCompletedScoliosis Idiopathic | Scoliosis; AdolescenceTurkey
-
Hasan Kalyoncu UniversityCompletedScoliosis Idiopathic | Scoliosis; AdolescenceTurkey
Clinical Trials on ERAS program
-
Grupo Español de Rehabilitación MultimodalInstituto Aragones de Ciencias de la Salud; Instituto de Investigación Sanitaria...Recruiting
-
Peking University Cancer Hospital & InstituteRecruiting
-
The Affiliated Hospital of Qingdao UniversityQilu Hospital of Shandong University; Shandong Provincial Hospital; Qianfoshan... and other collaboratorsRecruitingStomach Neoplasms | Frail ElderlyChina
-
Instituto Brasileiro de Controle do CancerWithdrawnEnhanced Recovery After Surgery | Gynecologic Surgical ProceduresBrazil
-
Instituto Brasileiro de Controle do CancerRecruitingGynecologic Cancer | Enhanced Recovery After SurgeryBrazil
-
First Affiliated Hospital of Chongqing Medical...UnknownPostoperative ComplicationsChina
-
St. Borbala HospitalSemmelweis University; St. Borbala Hospital, Department of SurgeryCompletedColorectal Cancer | Insulin ResistanceHungary
-
Instituto de Investigación Sanitaria de la Fundación...Completed
-
Erasca, Inc.Active, not recruitingAdvanced or Metastatic Solid TumorsUnited States