Is the Residual Gastric Volume After Sleeve Gastrectomy an Objective Criterion to Adapt the Treatment Strategy After Failure?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- calculation of the BAROS Score
研究概览
简要总结
Obesity is a worldwide health problematic whose incidence is increasing especially in developed countries. The surgical management of this illness consists in different techniques such as Laparoscopic Sleeve Gastrectomy but this treatment could not be efficient enough. The causes of failure after Laparoscopic Sleeve Gastrectomy are not known but could include the residual gastric volume.
The aim of the present study was to determine whether the residual gastric volume is involved in Laparoscopic Sleeve Gastrectomy's failure.
详细描述
This study can be done in three steps:
- From a prospective database, patients are selected if they were operated by Laparoscopic Sleeve gastrectomy at least two years before.
- these patients are convoked by their surgeon, who proposed them to participate at this study. During this consultation, the BAROS score is calculated by the surgeon and reported in the case report form of the patient.
- After checking the possible contraindication, a gastric computed tomography volumetry is done and the residual gastric volume is calculated by two independent radiologists.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •older than 18 years old
- •laparoscopic Sleeve gastrectomy performed two years before
- •surgery performed in the digestive surgery department of the Amiens University Hospital
排除标准
- •pregnancy or breastfeeding
- •death of the patient or lost of follow-up
- •patient under legal or administrative protection
- •contraindication to the volumetry (pregnancy, technical impossibility)
结局指标
主要结局
calculation of the BAROS Score
时间窗: during the consultation two years after the surgery
the BAROS Score is calculated by the surgeon and corresponds to the presence of a failure of Laparoscopic Sleeve Gastrectomy
次要结局
- measure of the residual gastric volume by the radiologists(two years after the surgical procedure)