Medico Economic Evaluation of a Temporary (6 Months) Intra-gastric Balloon in Morbidly Obese Patients Before a Gastric By-pass. A Randomised Multicenter Study Comparing the Usual Strategy to Two Types of Gastric Balloon
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 314
- 试验地点
- 2
- 主要终点
- Rate of admission in Intensive Care Units
研究概览
简要总结
To demonstrate, during a prospective randomized medico-economic study, in morbidly obese patients (BMI > 45 kg/m²) selected for a laparoscopic gastric by-pass that, in comparison to usual care, a temporary intra-gastric balloon (6 months) decreases medical costs and peri-operative morbidity.
详细描述
On inclusion, comorbidities associated with obesity will be recorded. After recording of the informed consent patients will be randomized in two groups: usual care or intra-gastric balloon. In the latter, a second randomization will be performed between air-filled balloon or water-filled balloon. Six months later, after withdrawal of the balloon (if required), laparoscopic gastric by-pass will be performed. Thereafter, patients will be followed during 6 months.
On each visit, inclusion, 3 months, 6 months, surgery, 1 month and 6 months post surgery, a medical and biological evaluation will be systematically performed.
The main criteria of judgement is the rate of admission in ICU during more than 24 hrs during the 30 days following surgery.
The secondary criteria of judgement is: the differences in pre-operative weight loss between the 2 groups, number of complications occurring during the 30 days after surgery, differences in different scales of quality of life (SF36, IWQOL-lite), differences in operative time, length of hospital stay, readmissions, and medical cots between the two strategies. Efficacy and tolerance of each type of balloon (air-filled or water-filled) will be compared in the intra-gastric balloon group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 75 years
- •Patients with morbid obesity with BMI > 45 kg/m² requiring a gastric by-pass by laparoscopy.
- •No efficacy of previous treatment on obesity
- •Firmed informed consent
排除标准
- •Patients in whom laparoscopy is contra-indicated
- •Indication of gastric by-pass by laparoscopy retained without multidisciplinary advice
- •Morbid obesity present since less than 5 years
- •Severe associated pathology, non-related to obesity, impairing vital prognosis on a short or mean time
- •Past history of gastric surgery, or gastric complication related to gastric lap-band
- •Lack of health insurance
- •Patient refusing to be followed 6 months before and after surgery
- •Drug abuse
- •Pregnancy or foreseeable pregnancy during the study
- •Patients taking anticoagulant agents or steroids
- •Patients with hiatal hernia > 4 cm
- •Patients with active ulcerated esophagitis (grade C-D in Los Angeles Classification)
- •Patients with duodenal or gastric ulcer
- •Patients with gastric or esophageal varices
- •Patients with NSAIDs not taking PPI
- •Patients with bulimia
结局指标
主要结局
Rate of admission in Intensive Care Units
时间窗: > 24 hrs during the 30-day period following gastric by-pass
次要结局
- Differences in absolute weight loss(at 6 months, before gastric by-pass, between the 2 strategies)
- Number and types of complications occurring(during the 30-day post-operative period)
- Number of comorbidities present(after the 6-month initial period)
- Differences in quality of life(at the end of first 6-month period and at the end of the study)
- Differences in time of surgery, length of stay, readmission(during the 30-day post by-pass period)
- Differences in medical costs between the 2 strategies(6 months before and after gastric by-pass)