Effects of Neuromuscular Scoliosis Surgery on Nutritional Metabolism

Обзор

Cerebral palsy is the primary cause of disability in France. It is a non-progressive condition leading to movement and posture troubles, but also to cognitive and sensory problems. Spasticity is one of the most regular consequences. It leads to a muscular failure with permanent contractions. Muscular dysfunction can generate scoliosis (in 60% of cases). Scoliosis can lead to pain, sitting difficulties (with chances of bedsores), and cardiopulmonary complications. 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.

Вмешательства

• Диагностический тест 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
• Поведенческое 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

Первичные конечные точки

• Dietary intakes modifications before and after scoliosis surgery [Срок оценки: Between 1 month before surgery and 6 months after surgery]

Вторичные конечные точки (12)

• Dietary intakes modifications before and after scoliosis surgery [Срок оценки: Between 1 month before surgery and 3 months after surgery]
• Weight comparison before and after scoliosis surgery [Срок оценки: Between 1 month before surgery and 6 months after surgery]
• Weight comparison before and after scoliosis surgery [Срок оценки: Between 1 month before surgery and 3 months after surgery]
• Assessment of the quality of life before and after scoliosis surgery [Срок оценки: Between 1 month before surgery and 6 months after surgery]
• Assessment of the quality of life before and after scoliosis surgery [Срок оценки: Between 1 month before surgery and 3 months after surgery]
• Change of respiratory rate before and after surgery [Срок оценки: Between 1 month before surgery and 6 months after surgery]
• Change of respiratory rate before and after surgery [Срок оценки: Between one month before surgery and three months after surgery]
• Change of metabolic rate before and after surgery [Срок оценки: Between 1 month before surgery and 6 months after surgery]
• Change of weight distribution before and after surgery [Срок оценки: Between one month before surgery and six months after surgery]
• Assessment of the achievement of customized goals established one month before the scoliosis surgery [Срок оценки: 3 months after surgery]
• Assessment of the achievement of customized goals established one month before the scoliosis surgery [Срок оценки: 6 months after surgery]
• Change of hypoxemia before and after surgery [Срок оценки: Between 1 month before surgery and 3 months after surgery]

Критерии участия

Критерии включения

• Subjects with cerebral palsy
• 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

Критерии исключения

• History of spine surgery
• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 1 центр

• University hospital Montpellier — Montpellier

Идентификаторы

NCT: NCT07255495 · RECHMPL25_0018

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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