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临床试验/NCT01980420
NCT01980420已完成不适用

Prospective Study of the Impact of Sleeve Gastrectomy on Gastro-esophageal Junction Function

IHU Strasbourg2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2013年11月1日最近更新:
适应症

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

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)

研究者

发起方
IHU Strasbourg
申办方类型
Other
责任方
Sponsor

研究点 (2)

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