Early Standing in Minors Operated on for Idiopathic Scoliosis

NCT06152601 | Recruiting

• 1 other identifier: RC31/21/0611
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Idiopathic Scoliosis; ERAS

Keywords

idiopathic scoliosis; physiotherapies; ERAS

Outcome Measures

Primary Outcomes (1)

• success of the anticipated bipedal standing position within 6 hours postoperative

  success of a Stand up in a bipedal standing position during more than 3 seconds in the post-operative phase within 6 hours postoperative. The procedure of anticipated bipedal standing position is realised according to the same procedure as usual but carried out in advance, at six hours postoperative, after validation of the prerequisites for the procedure.

  Hour 6

Secondary Outcomes (11)

• pain measured by visual analog scale at baseline

  day 0

• pain measured by visual analog scale at the first day postoperative

  day 1

• pain measured by visual analog scale at the second day postoperative

  day 2

• pain measured by visual analog scale at the third day postoperative

  day 3

• Morphine consumption baseline

  Day 0

Study Arms (1)

Group experimental

EXPERIMENTAL

Patient between 12 and 18 years old with a spinal surgery for idiopathic scoliosis programmed. Immediately postoperatively, during his stay in a PACU or ICU, the patient will be offered a physiotherapy session including a lifting phase in a bipedal standing position.

Procedure: anticipated bipedal standing position in the immediate post-operative phase

Interventions

anticipated bipedal standing position in the immediate post-operative phase PROCEDURE

Realization of a first stand-up within 6 hours after entry into PACU or extubation for admitted patients intubated, in PACU or on admission to ICU by a state-certified physiotherapist. Immediately postoperatively, during his stay in a Intensive Care Unit, the patient will be offered a physiotherapy session including a lifting phase in a bipedal standing position.

Group experimental

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

CHU de TOULOUSE

Toulouse, 31000, France

RECRUITING

Study Officials

• François Dr DELORT

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

François Dr DELORT

CONTACT

05 34 55 85 33; delort.f@chu-toulouse.fr

Delphine Dr KERN

CONTACT

kern.d@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2023
• First Posted: November 30, 2023
• Study Start: March 19, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 21, 2024

Record last verified: 2024-03

Locations

FR (1)