Early Standing in Minors Operated on for Idiopathic Scoliosis (NCT06152601) | Clinical Trial Compass
CompletedNot Applicable
Early Standing in Minors Operated on for Idiopathic Scoliosis
France30 participantsStarted 2024-03-19
Plain-language summary
The implementation of an enhanced rehabilitation after surgery (ERAS) program in major orthopedic surgery and in scoliosis surgery in children and adolescents has become a marker of good practice. Investigators are already applying anesthetic, surgical, peri-operative medicine and rehabilitation techniques allowing accelerated and improved rehabilitation for scoliosis operated patients in the establishment. To improve patient care, the Investigators want to develop the ERAS program. The objective of this research will be to validate the feasibility of getting up early on D0 in post-anesthesia care unit (PACU) or ICU in children who have just had surgery for idiopathic scoliosis.
Who can participate
Age range
12 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Programming of spinal surgery via the posterior approach for idiopathic scoliosis eligible for an ERAS program
* Person affiliated or beneficiary of a social security scheme
* Free, informed and written consent signed by the legal guardians of the minor patient
* Free and informed consent of the minor patient
Exclusion Criteria:
* Scoliosis linked to a neuromuscular pathology
* Physical status score of American Society of Anesthesiologists (ASA) \> 2
* Severe or unbalanced associated conditions (cardiac, pulmonary, coagulopathy or anticoagulant treatment with curative intent, long-term corticosteroid therapy)
* Malnutrition
* Major cognitive disorders
* Impossibility for the parent(s) to contact the pediatrician or the hospital service if necessary (minor patients)
* Pregnancy
* Feeding with milk
* Severe disability related to scoliosis with impossibility of ambulation
* Surgical assembly planned unstable or requiring the wearing of a corset
* Refusal of minor patient or of the legal guardians of the minor patient
* Patient under legal protection, guardianship or curatorship
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
success of the anticipated bipedal standing position within 6 hours postoperative