ScoliosisRAACNCT04012528
ERAS and Pediatric Scoliosis Surgery
An observational study of Scoliosis, run by University Hospital, Montpellier at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Scoliosis
- What is being tested?
- ERAS program
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2018to 30 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Chidren and teenager admitted for scoliosis surgery
Who may be able to join
- patient with age < 18 years
- patient scheduled for scoliosis surgery
Who cannot join
- patient with age > 18years
- patient with medical follow up by pediatric chronic pain departement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Scoliosis
- Being tested
- ERAS program
- Keywords
- Pediatric, Surgery, Rehabilitation
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERAS programOther
ERAS program
| Study group | Role | What they receive |
|---|---|---|
| "the before" group | 75 teenagers after scoliosis surgery before ERAS program implementation Receives: Other: ERAS program | |
| "the after" group | 75 teenagers after scoliosis surgery after ERAS program implementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative length of hospital stay
Postoperative length of hospital stay
Measured: up to 4 weeks after surgery
Secondary outcomes (4)
Number of Antalgics consumption
Antalgics consumption including opioids and non-opioids drug
Measured: up to 15 days after surgery
Time to oral diet tolerance
Able to eat without abdominal discomfort, nausea, or vomiting
Measured: up to 15 days after surgery
Time to first bowel motion
Able to eat without abdominal discomfort, nausea, or vomiting
Measured: up to 15 days after surgery
Time to first verticalization
Able to eat without abdominal discomfort, nausea, or vomiting
Measured: up to 15 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2019
- Study start1 Jan 2018
- Primary completion1 Nov 2020
- Study completion30 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScoliosisStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chrystelle CS SOLA, MD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04012528
- Sponsor's protocol ID
- RECHMPL18_0382
- Acronym
- RAAC
- Status last verified
- Dec 2020
- First submitted
- 26 Apr 2019
- Last updated
- 29 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assesment of Enhanced Recovery After Pediatric Idiopathic Scoliosis Surgery
- ClinicalTrials.gov ID
- NCT04012528
- Acronym / sponsor ID
- RAAC / RECHMPL18_0382
- Conditions
- Scoliosis
- Keywords
- Pediatric, Surgery, Rehabilitation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 30 Nov 2021 (estimated)
- First posted
- 9 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "the before" group | – | Other: ERAS program75 teenagers after scoliosis surgery before ERAS program implementation |
| "the after" group | – | –75 teenagers after scoliosis surgery after ERAS program implementation |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Chidren and teenager admitted for scoliosis surgery
Key inclusion criteria (2 listed)
- patient with age < 18 years
- patient scheduled for scoliosis surgery
Key exclusion criteria (2 listed)
- patient with age > 18years
- patient with medical follow up by pediatric chronic pain departement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ERAS programERAS program | Other | "the before" group |
Primary outcome
Postoperative length of hospital stay
Time frame: up to 4 weeks after surgery
Postoperative length of hospital stay
4 secondary outcomes
Number of Antalgics consumption
Time frame: up to 15 days after surgery
Time to oral diet tolerance
Time frame: up to 15 days after surgery
Time to first bowel motion
Time frame: up to 15 days after surgery
Time to first verticalization
Time frame: up to 15 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2020.
- Individual participant dataSharing planned: Undecided. NC
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chrystelle CS SOLA, MD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scoliosis, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative length of hospital stay (time frame: up to 4 weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2020.