Prospective Study of the Impact of Sleeve Gastrectomy on Gastro-esophageal Junction Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Number of patients with postoperative GIQLI score greater than preoperative score
研究概览
简要总结
Improved results for sleeve gastrectomy could be possible if more was known about the surgical / mechanical factors that affect outcome.
详细描述
Effectiveness of sleeve gastrectomy is between gastric banding and gastric bypass. However, a proportion of patients that undergo surgery, report troublesome and persistent dysphagia, pain, new onset or worsening of gastro-esophageal reflux (GER) requiring treatment. Improved results for sleeve gastrectomy could be possible if more was known about the surgical / mechanical factors that affect outcome. Current investigations based on traditional intra-luminal imaging (endoscopy) and radiology (UGI series) may not provide adequate preoperative assessment of esophago-gastric dynamics. Current practice in the creation of a sleeve gastrectomy involves the use of a bougie or endoscope around which the sleeve is stapled. There is no consensus on the diameter of this bougie and this intraoperative calibration may alter the gastro-esophageal junction (GEJ) anatomy, does not provide real time physiology feedback, and allows only for a rough approximation of the size of the sleeve providing no information about the distensibility and pressure gradient of the newly created gastric tube as it is filled. A more distensible sleeve will have lower intra-gastric pressure, and thus will theoretically be expected to reduce the incidence of side effects. As laparoscopic sleeve gastrectomy is performed with increasing frequency, there is a need for development of tools to assist the surgeon in modeling properly and standardize the gastroplasty. This study will be based on a strict assessment of the anatomical and functional characteristics of the "ideal "gastric sleeve, using existing imaging modalities (endoscopy - CT scan- MRI - HRM).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Patient, male or female over 18 years old
- •Patient scheduled to undergo a sleeve gastrectomy for obesity
- •Patient with surgical indication validated by the obesity multidisciplinary meeting (RCP)
- •Patient able to understand the study and to provide written informed consent
- •Patient registered with the French social security regime
- •Non-inclusion criteria:
- •Patient unable to give written informed consent
- •Patient presenting contra-indication to the conduct of an MRI (claustrophobia, implantable medical devices)
- •Patient presenting risks of allergic reaction to MRI contrast agents (gadolinium)
- •Patient presenting, in the investigator's judgment, a condition or disease preventing their participation to study procedures
- •Patient pregnant or breast-feeding
- •Patient within exclusion period from other clinical trial
- •Patient having forfeited their freedom of an administrative or legal obligation
- •Patient being under guardianship
排除标准
- 未提供
结局指标
主要结局
Number of patients with postoperative GIQLI score greater than preoperative score
时间窗: 50% excess weight loss (about 6 months post surgery)
Patients with postoperative GIQLI (Gastro-Intestinal Quality of Life Index) score greater than preoperative score
次要结局
- Quality of life (GIQLI)(50% of excess weight loss (about 6 months post surgery))
- Functional examinations(50% of excess weight loss (about 6 months post surgery))
- Cost of exploratory exams(Within 2 months prior to surgery)
- GERD and dysphagia symptoms (GSAS questionnaire)(50% of excess weight loss (about 6 months post surgery))
- EndoFLIP® measures(Intra-operatively)
- Per and post-operative complications(within 6 months post surgery)
- Surgical video analysis(within 6 months post surgery)
