Effects of Neuromuscular Scoliosis Surgery on Nutritional Metabolism
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Dietary intakes modifications before and after scoliosis surgery
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: Absorptiometry and indirect calorimetry (Diagnostic Test)
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
干预措施: Questionnaires (Behavioral)
结局指标
主要结局
Dietary intakes modifications before and after scoliosis surgery
时间窗: Between 1 month before surgery and 6 months after surgery
Assessment of the dietary intakes in kcal/day (dietary intakes per os and/or gastrostomy and/or nasogastric tube) by nutrition questionnaires and based on the average food intake over the last 7 days. Caregivers will provide information on food intake for each day and each meal during the seven days preceding the consultation using a food intake sheet. A standardized table will be used to calculate the equivalents between food intake and energy intake (kcal). An average will be calculated over the 7 days to obtain a dietary intake in kcal/day. Comparison of the dietary intakes between one month before scoliosis surgery and six months after surgery
次要结局
- Weight comparison before and after scoliosis surgery(Between 1 month before surgery and 6 months after surgery)
- Assessment of the quality of life before and after scoliosis surgery(Between 1 month before surgery and 6 months after surgery)
- Change of respiratory rate before and after surgery(Between 1 month before surgery and 6 months after surgery)
- Assessment of the achievement of customized goals established one month before the scoliosis surgery(3 months after surgery)
- Change of hypoxemia before and after surgery(Between 1 month before surgery and 3 months after surgery)
- Change of hypercapnia before and after surgery(Between 1 month before surgery and 3 months after surgery)
- Change of tidal volume before and after surgery(Between 1 month before surgery and 3 months after surgery)
- Dietary intakes modifications before and after scoliosis surgery(Between 1 month before surgery and 3 months after surgery)
- Weight comparison before and after scoliosis surgery(Between 1 month before surgery and 3 months after surgery)
- Assessment of the quality of life before and after scoliosis surgery(Between 1 month before surgery and 3 months after surgery)
- Change of respiratory rate before and after surgery(Between one month before surgery and three months after surgery)
- Change of metabolic rate before and after surgery(Between 1 month before surgery and 6 months after surgery)
- Change of weight distribution before and after surgery(Between one month before surgery and six months after surgery)
- Assessment of the achievement of customized goals established one month before the scoliosis surgery(6 months after surgery)
- Change of hypoxemia before and after surgery(Between 1 month before surgery and 6 months after surgery)
- Change of hypercapnia before and after surgery(Between 1 month before surgery and 6 months after surgery)
- Change of tidal volume before and after surgery(Between 1 month before surgery and 6 months after surgery)