Endoscopic Gastric Tubulization
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Change in weight loss
研究概览
简要总结
Endoscopic gastric tubulization is currently proposed in the Digestive Surgery Department of the Nouvel Hôpital Civil, Strasbourg, France, to adult patients with morbid obesity. The procedure is performed using the CE marked endoscopic suture device Overstitch (Apollo Endosurgery, Austin, Tx. USA). It is standard practice since October 2016.
The objective of this study is to prospectively collect data of patients who underwent an endoscopic gastric tubulization, from last visit before procedure to 2 years after procedure. These data are usually collected during medical consultations and will enable the evaluation of weight loss, quality of life and comorbidities improvement, reproducibility and durability of the technique.
详细描述
Gastric restriction is one of the fundamental principles of gastric bypass and gastric banding. Despite its advantages (long term weight loss, comorbidities related to obesity improvement...), bariatric surgery is risky. In fact, complications putting the patient into a life-threatening condition can occur. Endoscopic approaches are similar to current surgical methods but less invasive, safer and allow ambulatory care.
Nowadays, practitioners have the possibility to reduce stomach size by merging tissues through an endoscopic endoluminal suture approach without any incision. This leads to similar results (gastric restriction, weight loss, quality of life and comorbidities improvement) compared with standard surgical procedure while reducing the risk of complications.
One of the major benefit of this technique is its reversibility. A new surgical or endoscopic procedure is possible at a later stage.
Endoscopic gastric tubulization is currently proposed in the Digestive Surgery Department of the Nouvel Hôpital Civil, Strasbourg, France, to adult patients with morbid obesity. The procedure is performed using the CE marked endoscopic suture device Overstitch (Apollo Endosurgery, Austin, Tx. USA). It is standard practice since October 2016.
The objective of this study is to prospectively collect data of patients who underwent an endoscopic gastric tubulization, from last visit before procedure to 2 years after procedure. These data are usually collected during medical consultations and will enable the evaluation of weight loss, quality of life and comorbidities improvement, reproducibility and durability of the technique.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for an endoscopic gastric tubulization in the Nouvel Hôpital Civil, Strasbourg, France
排除标准
- 未提供
结局指标
主要结局
Change in weight loss
时间窗: 7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure
Change in weight loss measured in kilograms.
Change in body mass index variation
时间窗: 7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure
Change in body mass index variation measured in kg/m².
Change in excess weight loss
时间窗: 7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure
Change in excess weight loss measured in percentage. Excess weight loss = (weight loss at time point / weight loss goal to reach a body mass index of 25 kg/m²) x 100
次要结局
- Procedure duration(At time of procedure)
- Number of patients with procedure-related adverse event(7 days, 1 - 3 - 6 - 9 and 12 months after procedure)
- Comorbidities improvement(7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure)
- Quality of life improvement(3 - 12 - 18 and 24 months after procedure)
- Gastro-intestinal quality of life improvement(3 - 12 - 18 and 24 months after procedure)
- Modification in the feeling of satiety(1 - 3 - 6 - 12 - 18 and 24 months after procedure)
- Upper GI tract radiologic evaluation(1 day, 6 - 12 and 24 months after procedure)
- Upper GI tract endoscopic evaluation(6 - 12 and 24 months after procedure)
- Number of stitches in place(At time of procedure)