Effects of Neuromuscular Scoliosis Surgery on Nutritional Metabolism
NCT ID: NCT07255495
Last Updated: 2025-12-17
Study Results
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Basic Information
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NOT_YET_RECRUITING
NA
42 participants
INTERVENTIONAL
2026-01-30
2029-01-30
Brief Summary
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These children often have cachexia (eating difficulties, trouble with deglutition). It leads to a weakening of their immune defenses, which favors post-operative infections, a weakening of their respiratory muscles, and circulatory difficulties with negative effects on scarring. Cachexia is a pessimistic prognosis.
A back brace can be used to contain the scoliosis but never cures it. Another option for treating this affection would be surgery. Surgery is another treatment. It consists in straightening and holding the spine with metal rods, held by vertebral anchors placed at both ends of the scoliosis. Surgery is the gold standard.
Surgery induces risks such as bleeding, healing complications and infection. The probability to face complications increases with malnutrition.
The first hypothesis is that surgery could improve the nutrients intakes and the weight of the patient.
The investigators also believe that it could improve the patient's body composition (body fat and lean mass) and their basic metabolic rate.
The third hypothesis is that surgery-involved changes (nutrition enhancement, sitting improvement, decrease of respiratory work) could lead to an improvement of the patient's quality and life and respiratory functions.
The SORONOUS project aim to prove the benefits of this surgery from a nutritional and from a general point of view in order to help make the surgical decision and avoid any care delay. In addition, it aim to identify and quantify the post-operative weight gain; while providing us with a better understanding of the behavior of pre-operative cachexia among these patients.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Assessment of group before and after spinal surgery
Assessment of food intake, body composition, energy expenditure, quality of life, achievement of customized goals before and after spinal surgery
Absorptiometry and indirect calorimetry
Assessment of body composition with dual-energy absorptiometry : 1 month before surgery and 6 months after surgery
Assessment of energy expenditure with indirect calorimetry : 1 month before surgery and 6 months after surgery
Questionnaires
Assessment of food intake with a standardized questionnaire : 6 months before surgery, 1 month before surgery, 3 months after surgery and 6 months after surgery
Assessment of quality of life with the CP Child Score questionnaire : 6 months before surgery, 1 month before surgery, 3 months after surgery and 6 months after surgery
Assessment of the achievement of customized goals established one month before the scoliosis surgery : 3 months after surgery and 6 months after surgery
Interventions
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Absorptiometry and indirect calorimetry
Assessment of body composition with dual-energy absorptiometry : 1 month before surgery and 6 months after surgery
Assessment of energy expenditure with indirect calorimetry : 1 month before surgery and 6 months after surgery
Questionnaires
Assessment of food intake with a standardized questionnaire : 6 months before surgery, 1 month before surgery, 3 months after surgery and 6 months after surgery
Assessment of quality of life with the CP Child Score questionnaire : 6 months before surgery, 1 month before surgery, 3 months after surgery and 6 months after surgery
Assessment of the achievement of customized goals established one month before the scoliosis surgery : 3 months after surgery and 6 months after surgery
Eligibility Criteria
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Inclusion Criteria
* Subjects between 10 and 20 years old
* Neuromuscular scoliosis requiring surgical care (accepted by the patient or their legal representatives)
* Subjects escaping scoliosis treatment with a brace
Exclusion Criteria
* Impossible follow-up during the study time
* Peripheral or non spastic palsy
* Palsy caused by a medullary injury
* Subject with a contraindication to DXA scan examination (e.g. coronary stents or cardiac metal sutures, pacemaker or automatic defibrillator)
* Absence of voluntary and informed consent signed by the patient or their legal representatives
* Patient or their legal representatives with no social security affiliation
* Patient or their legal representatives deprived of freedom by a judicial or administrative decision
* Pregnant, laboring, or breastfeeding woman
10 Years
20 Years
ALL
No
Sponsors
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University Hospital, Montpellier
OTHER
Responsible Party
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Locations
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University hospital Montpellier
Montpellier, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RECHMPL25_0018
Identifier Type: -
Identifier Source: org_study_id