Assessing the Impact of an Educational Personalized Clinical Support Device Preventive and a Referent Nurse in Surgery for Obesity With the Risk of Occurrence of Dumping Syndrome After Gastric Bypass.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 135
- 试验地点
- 4
- 主要终点
- The frequency of dumping syndrome
研究概览
简要总结
The postprandial dumping syndrome is a frequent consequence of Roux-en-Y Gastric ByPass due to the rapid emptying of the stomach remnant in to the intestinal lumen. Dumping-related symptoms occur very early after eating (within 30 minutes), are not associated with concurrent hypoglycemia, and are most prominent in the early postoperative period. This syndrome very debilitating for the patient can be improved by dietary and nutritional recommendations. We hypothesize that a personalized approach based on dietary and nutritional recommendations conducted by a nurse would likely to decrease the frequency of dumping syndrome and improve the postoperative quality of life of patients in the early postoperative period.
详细描述
The Roux-en-Y Gastric ByPass is considered the gold standard of weight loss surgery and is the most commonly performed bariatric procedure worldwide.The postprandial dumping syndrome is a frequent consequence of gastrojejunal anastomosis due to the rapid emptying of the stomach remnant in to the intestinal lumen. Dumping-related symptoms occur very early after eating (within 30 minutes), are not associated with concurrent hypoglycemia, and are most prominent in the early postoperative period. The symptoms of dumping syndrome include nausea, abdominal cramps, diarrhea, dizzy spells, weakness and cold sweats either with or after eating.This syndrome very debilitating for the patient can be improved by dietary and nutritional recommendations. We hypothesize that an individualized approach based on dietary and nutritional recommendations and monitoring of patients conducted by a nurse in the first three months after surgery would likely to decrease these problems and improve the postoperative quality of life of patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body Mass Index ≥40 kg / m2 or ≥35 kg / m2 in the presence of comorbidities related to obesity
- •Indication to Roux-en-Y Gastric ByPass
排除标准
- •Contraindication to Roux-en-Y Gastric ByPass
- •Refusal to sign the consent form
- •Patient not affiliated to a social security system
- •Pregnancy
研究组 & 干预措施
Dietary and nutritional recommendations
Postoperative personalized approach based on dietary and nutritional recommendations conducted by a nurse
干预措施: Dietary and nutritional recommendations conducted by a nurse (Behavioral)
Standard of care
Postoperative standard of care
结局指标
主要结局
The frequency of dumping syndrome
时间窗: 3 months
The frequency of dumping syndrome at 3 months will be compared between the two groups.
次要结局
- Personal Effectiveness Assessment questionnaire (SEPOB)(3 months)
- Change in Body Mass Index(3 months)
- Frequence of Adverse Events after surgery(at 1 and 3 months)
- Quality of Life-Lite questionnaire(3 months)