Not yet recruitingNAINTERVENTIONAL

Multicentric Evaluation of Enhanced Recovery After Surgery Protocol in Adolescent Idiopathic Scoliosis Surgery

This study explores how to improve recovery for teenagers having surgery for adolescent idiopathic scoliosis, a condition causing a curved spine. Around 2-4% of young people under 18 have this, and severe cases often need surgery to straighten the spine with metal rods. This can be a big worry for families due to the risks and recovery time. The study compares two approaches: the standard recovery plan and an 'Enhanced Recovery After Surgery' (ERAS) plan. ERAS is a package of care designed to help patients recover more quickly from operations by reducing pain, getting them moving sooner, and generally making the whole process smoother. Researchers want to see if ERAS can shorten hospital stays and improve quality of life after surgery for these young patients.

At a glance

Status

Not yet recruiting

Phase

Sponsor

Hospices Civils de Lyon

Enrolment target

316

Start

01 May 2025

Estimated completion

01 Apr 2029

Idiopathic Scoliosis

What is this study about?

Scoliosis is when your spine, or backbone, has a curve. For some teenagers, this curve can become quite big and affect their physical health or how they feel about themselves. If the curve is severe, usually 40 degrees or more, doctors might suggest an operation. This surgery, called posterior vertebral fusion, aims to straighten the spine using bone grafts and two metal rods, which stay in place permanently to help the spine heal straight.

Understandably, the idea of spine surgery can be worrying for both teenagers and their parents. While serious complications are very rare, the surgery does involve a large incision, can reduce spine movement in that area, and often leads to tiredness for several weeks afterwards due to blood loss. Patients usually need strong pain relief, including morphine, and typically stay in hospital for 5 to 7 days, followed by 1 to 2 months of recovery at home or in a special centre.

This study looks at something called 'Enhanced Recovery After Surgery' (ERAS). ERAS is a modern approach to care that bundles together various methods to help patients recover faster and better from operations. This includes things like preparing thoroughly before surgery, using special techniques during the operation to reduce blood loss and pain, and providing excellent pain relief and follow-up care afterwards. ERAS has been successful in many other adult and children's surgeries. The main goal of this particular study is to find out if using an ERAS plan for teenagers having scoliosis surgery can significantly shorten their time in hospital and improve their quality of life after the operation, compared to the standard care they would normally receive.

Key takeaways

This study compares standard care to an 'Enhanced Recovery After Surgery' (ERAS) plan for teenagers with scoliosis.
The goal is to see if ERAS can shorten hospital stays and improve recovery and quality of life after spinal fusion surgery.
It involves teenagers aged 11-17 needing surgery for adolescent idiopathic scoliosis.
Participation includes receiving one of two care plans and having your recovery monitored.
The surgery itself (spinal fusion with rods) is common for severe curves.
The study aims to provide strong evidence for the benefits of ERAS in this specific group.

Who may be eligible?

This study is looking for teenagers who are between 11 and 17 years old. They must have been diagnosed with adolescent idiopathic scoliosis, which is a common type of curved spine in young people, and their doctors must have decided that they need posterior spinal fusion surgery to fix it.

Before taking part, both parents or legal guardians will need to give their written permission for their child due to their age.

Some young people won't be able to join the study. This includes those with other significant health problems (like breathing difficulties or diabetes), anyone who has had spine surgery before, or those who are pregnant or receiving mental health care. Anyone with legal protection like guardianship will also not be able to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 11 and 17 years old?
Have you been diagnosed with adolescent idiopathic scoliosis?
Has your doctor recommended posterior spinal fusion surgery?
Do you have a health insurance plan?
Are you free from other significant health conditions like diabetes or breathing problems?
Have you never had spine surgery before?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you will either receive the standard care for your scoliosis surgery or the new 'Enhanced Recovery After Surgery' (ERAS) plan. We don't yet know which is better, so your care will be decided by chance, like flipping a coin. Both approaches involve the same Posterior vertebral fusion surgery to correct your curved spine.

Beyond your surgery and hospital stay, which you would have anyway, the study will involve regular check-ups to see how you are recovering. This includes assessing your pain levels, how long you stay in hospital, and your general well-being and quality of life after the operation. Researchers will also keep in touch after you go home to see how your recovery is progressing. The total duration of your participation in the study, including follow-up, will be determined by the study protocol, but the aim is to track your recovery and quality of life for longer than previous studies, beyond 6 months.

Potential risks and benefits

Taking part in this study may offer some benefits, especially if you receive the ERAS plan, which aims to reduce your hospital stay and improve your recovery and quality of life after surgery. However, there's no guarantee of direct benefit to you, as this is a research study to see if ERAS is better than standard care. Like any surgery, spinal fusion carries risks, including pain, potential infection, blood loss, and in very rare cases, more serious complications. The study itself doesn't add new risks beyond those of the surgery itself, as both groups undergo the same surgical procedure. Your medical team will discuss all potential risks with you in detail. Remember, you can choose to withdraw from the study at any time without affecting your medical treatment.

Locations (11)

CHU d'Amiens Site Sud
Verified postcode
Amiens, France
CHU de Besançon Hopital Jean Minjoz
Verified postcode
Besançon, France
Pediatric orthopedic surgery unit Hôpital femme Mère Enfant (HFME)
Verified postcode
Bron, France
CHU de Grenoble Hôpital Couple Enfant
Verified postcode
La Tronche, France
Centre Medico-Chirurgical de Réadaptation des Massues Croix-Rouge
Verified postcode
Lyon, France
AP-HM Hôpital de la Timone
Verified postcode
Marseille, France
Fondation LENVAL
Verified postcode
Nice, France
CHU de Saint-Etienne Hôpital Nord
Verified postcode
Saint-Priest-en-Jarez, France
CHU de Toulouse
Verified postcode
Toulouse, France
Clinique Médipôle Garonne
Verified postcode
Toulouse, France
Clinique St Leonard
Verified postcode
Trélazé, France

Common questions

What is scoliosis?

Scoliosis is when your spine has a sideways curve, often appearing during growth spurts before puberty. 'Idiopathic' means we don't know the exact cause.

What is 'Enhanced Recovery After Surgery' (ERAS)?

ERAS is a modern care plan that bundles together different methods before, during, and after surgery to help you recover faster and with less pain.

Will my hospital stay be shorter?

The study aims to see if the ERAS plan can reduce hospital stays for teenagers having scoliosis surgery, but this is what the research is trying to find out.

Is the surgery different in this study?

No, the surgery itself (posterior vertebral fusion) is the same for everyone. The study is comparing different ways of caring for you around the time of the operation.

Who is funding this research?

The information provided does not specify the funding source for this particular trial.

How to find out more

Vincent CUNIN

vincent.cunin@chu-lyon.fr 04 27 85 51 32 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.