Optimization and Follow-up of the Consecutive Use of Two Intragastric Balloons (Heliosphere Bag®) in the Treatment of Obesity: A Prospective Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Weight loss
研究概览
简要总结
This is a cohort study with the objective of describing during a 12-month follow-up, weight loss in obese patients submitted to treatment using two consecutively air-filled IGB (Heliosphere® 600 cc and Heliosphere 720 cc) without any interval between the removal of the first and the placement of the second.
详细描述
Intragastric balloon (IGB) implantation is a widely used technique to treat overweight subjects and those with mild obesity. The effectiveness of the air filled balloon (Heliosphere BAG®) in improving weight loss, reduction of BMI, percentage of body weight loss, percentage of excess weight loss and complications six months after placement is notable. Several methods are available for IGB placement and new techniques are being developed to reduce discomfort during and after the procedure. Thus, the use of an IGB as an effective method to avoid bariatric surgery is proposed. However, the precise protocol to balance complications and discomfort while maximizing weight loss is still to be established.
Our secondary objectives will be:
- Describe the weight loss, changes in the BMI and excess weight loss between the implantation of the first IGB until its removal;
- Describe changes in the components of the metabolic syndrome;
- Describe changes in blood pressure;
- Estimate the rate of early explant;
- Describe the conditions of surgery;
- Describe operative complications;
- To describe safety in the perioperative period, in the immediate postoperative period and in the late postoperative period
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Class I obesity (30-34.9 kg/m2), Class II obesity (35-39.5 kg/m2) or overweight (25-29.9 kg/m2).
排除标准
- •Morbid obesity (BMI>40kg/m2), operative contraindications.
结局指标
主要结局
Weight loss
时间窗: 12 months
Subtraction of the Final body mass index (BMI ) after 12 months of IGB placement minus the initial BMI
次要结局
- Change in blood pressure(12 months)
- Physical activity(12 months)
- Posoperative complications(Through posToperative period completion, an average of 72 hours after the termination of surgery)
- Rate of early explant(12 months)
- Operative complications(Through endoscopy completion, an average of 2 hours)
- Excess weight loss(12 months)
- Changes Glycated hemoglobin (HbA1c)(12 months)
- Caloric intake(12 months)