Evaluation of a Personalized Care Path After Bariatric Surgery Based on Monitoring the Weight Evolution Using a Connected Scale
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 390
- 试验地点
- 2
- 主要终点
- Evaluate the efficacy of new care pathway
研究概览
简要总结
Current guideline recommend yearly multidisciplinary postoperative follow-up after bariatric surgery. However, practices remain very heterogeneous, and only a fraction of patients are still follow-up beyond two years after the operation.
This study will assess a new care pathway in which the patients are follow-up according to the weight evolution measured by the patient using a connected scale.
详细描述
Bariatric surgery is developing rapidly. In France, the number of annual interventions increased threefold between 2001 and 2015, from 16,000 to 50,000 per year. This rapid development is explained by the well-demonstrated benefits of surgery: spectacular improvement in the quality of life, reduction in co-morbidities (diabetes, cardiovascular diseases, and steatohepatitis), and significant reduction in mortality linked to severe obesity. However, the benefits of surgery may decrease over time and may be associated with side effects.
Current guideline recommend yearly multidisciplinary postoperative follow-up after bariatric surgery. However, practices remain very heterogeneous, and only a fraction of patients are still follow-up beyond two years after the operation. The current recommendations therefore do not seem adapted to clinical reality. They do not prevent the regain of weight in many patients, which frequently leads to re-operations. Even more worrying is the possible occurrence of late complications, sometimes serious and life-threatening.
This study will assess a new care pathway in which the patients are follow-up according to weight evolution measured by the patient using a connected scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged> = at 18 years old Patients who have benefited from a Roux-en-Y Gastric By-Pass or Sleeve Gastrectomy bariatric surgery 2 years ago Preoperative Body Mass Index between 35 kg/m2 and 59 kg/m2 Access to the wired network at home. Social insured patient Patient who signed the informed consent
排除标准
- •Lack of autonomy for the use of remote monitoring equipment or psychological or psychiatric disorders making it difficult to optimally use the remote monitoring equipment
- •Administrative reasons: inability to receive informed consent information, inability to participate in the entire study, lack of social security coverage, refusal to sign consent, patient under guardianship or justice system.
研究组 & 干预措施
Control Group
In the control group, patients will follow a care pathway respecting the current recommendations : a systematic clinical visit scheduled each year with the multidisciplinary team.
干预措施: Control Group (Other)
Experimental Group
In the intervention group, patients will follow a new care pathway with visits triggered by weight evolution
干预措施: Intervention Group (Other)
结局指标
主要结局
Evaluate the efficacy of new care pathway
时间窗: 3 years
The main evaluation criterion is the success rate in terms of weight loss defined by an excess weight loss greater than 50%, in the absence undernutrition. Undernutrition is defined by a BMI \< 21 kg / m2 and / or an albumin level \<35 g /l
次要结局
- Frequency of Food Consumption Questionnaire(3 years)
- Change of nutritional parameters in the blood of vitamines(3 years)
- Change of nutritional parameters in the blood of protein(3 years)
- Dutch Eating Behavior Questionnaire (DEBQ)(3 years)
- Quality of life of SF36(3 years)
- Change of nutritional parameters in the blood of minerals(3 years)
- Ricci-Gagnon score(3 years)
- Cost-effectiveness of new care pathway(3 years)
- Number of visits made by the multidisciplinary team(3 years)
- Number of postoperative surgical and / or medical complications(3 years)
- Anxiety and depression by Hospital Anxiety and Depression Scale questionnaire (HAD)(3 years)
- Quality of life of questionnaire EQ-5D-5L(3 years)