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Gastric Volumetry by Gastric Tomodensitometry With Gas (VOLUSCAN)

2019年5月23日 更新者:Hospices Civils de Lyon

Evolution of Gastric Volume Measured by Gastric Tomodensitometry With Gas After Gastric Bypass Surgery or Sleeve Gastrectomy. Research for a Correlation With Weight Evolution : Pilot Study.

The Gastric bypass (GBP) is actually one of the most performed bariatric procedures worldwide. Short term results report 67% of mean Excess Weight Loss (EWL) at 2 years, and 58% EWL at 5 years. Sleeve gastrectomy (SG) which is a restrictive procedure has gained in popularity because of its technical simplicity and its efficiency (60% EWL at 1 year and 48% over 4 years). However, failures are observed because of insufficient weight loss or early weight regain. Several hypotheses have been proposed to explain these failures, such as the size of the gastric pouch that could be correlated to weight evolution.

Purpose of the study Taking the hypothesis that a progressive dilatation of the gastric pouch is one of the main factors of weight loss failure after GBP or SG due to the loss of its restrictive function, the aim of our study is to measure these gastric volumes using gastric tomodensitometry with gas, a new reliable,precise and 3 dimension radiological technique. The investigators will try to identify a positive correlation between gastric dilatation and weight regain.

Methods This is a 2 year interventional, prospective, monocentric study with longitudinal follow-up. Forty-five obese patients (BMI>40kg/m²) eligible for primary GBP (n=25) or SG (n=20) will be included. Gastric volumes will be measured by gastric tomodensitometry with gas at 3 and 12 month after surgery. In the GBP group, the investigators will measure the gastric pouch volume, the candy cane Roux limb volume, the neostomach volume (= gastric pouch+candy cane Roux limb) and the gastro-jejunal anastomosis diameter. In the SG group, the investigators will measure the volume of the gastric tube, of the non resectedantrum, of the whole residual stomach and the gastric tube diameter at the middle of the small curvature. Volume variations between 3 and 12 months will be compared to the EWL and to clinical and metabolic data (HbA1c, Insulinemia, HOMA index, liver steatosis). A 30% dilatation of the neostomach at 12 months will be considered as significant. Reinhold's criteria will be used to define surgical failure: EWL<50% at 12 months. Weight regain will be considered as significant if the weight reached at 12 months is higher than the minimum weight obtained. Gastric volume variation, EWL and BMI evolution between the 3rd and the 12th month will be analysed in the whole population and in each group (GBP and SG) with a Wilcoxon test.

Expected benefits If the investigators valid the hypothesis that the dilatation of the neostomach is an essential factor in weight regain after GBP and SG, the benefit for the patient will be dual: 1/ validate the prognostic value of gastric volumetry by gastric tomodensitometry with gas in order to explain weight regain, and in order to use it as a standard. 2/ the identification of specific risk factors related to the surgical procedure could result in surgical technique improvements as well as a better adaptation of revisional procedures, in order to improve treatment of recurrent obesity.

研究概览

研究类型

介入性

注册 (实际的)

46

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Lyon、法国、69003
        • Hospices Civils de Lyon- hôpital Edouard Herriot- service de Chirurgie Digestive

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 60年 (成人)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Patients of both genders, with morbid obesity (BMI > or = 40kg / m ²)
  • Age included between 18 and 60 years
  • Patient who requires a gastric bypass or a Sleeve gastrectomy as a 1st bariatric procedure. Indication validated in pluridisciplinary concertation meeting for bariatric surgery
  • No previous history of bariatric surgery
  • Free and informed consent signed
  • Being affiliated to a French social security system or similar.

Exclusion Criteria:

  • Bariatric surgery with metabolic aim (BMI < 40kg / m ²)
  • Patients with a history of bariatric surgery, after failure of one or several previous procedures
  • Contraindication to radiation exposition: current or planned pregnancy during the study
  • prostate adenoma : contraindication to antispasmodic
  • Known allergy to effervescent salts or butylscopolamine (Scoburen)
  • Glaucoma
  • Inability to express a consent
  • Unaffiliated patients to a French national insurance
  • Patients with Pacemaker
  • Patients already enrolled in a study with a conflict of interest with this study.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:诊断
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Patients with morbid obesity
Patients with morbid obesity and who requires a gastric bypass or a Sleeve gastrectomy as a 1st bariatric procedure.

研究衡量的是什么?

主要结果指标

结果测量
大体时间
the neostomach volume measured by gastrictomodensitometry with gas
大体时间:3 and 12 month
3 and 12 month
the subjects' weight at the 3rd and the 12th month after GBP or SG
大体时间:3 and 12 months
3 and 12 months

次要结果测量

结果测量
大体时间
the neostomach volume at 12 months and total weightloss
大体时间:12 month
12 month
determination of the positive predictive value of the neostomach volume at 3 months, on weight evolution at 12 months after GBP or SG
大体时间:3 and 12 month
3 and 12 month
the volume of the neostomach at 3 and 12 months between the subjects who gain weight and thosewho do not
大体时间:3 and 12 month
3 and 12 month
standard values for gastricvolumetry by gastrictomodensitometry with gas, at 3 and 12 months after GBP or SG
大体时间:3 and 12 month
3 and 12 month

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:MAUD ROBERT, MD、Hospices Civils de Lyon- Hôpital Edouard Herriot

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2012年9月1日

初级完成 (实际的)

2015年1月1日

研究完成 (实际的)

2015年1月1日

研究注册日期

首次提交

2013年10月10日

首先提交符合 QC 标准的

2013年10月11日

首次发布 (估计)

2013年10月16日

研究记录更新

最后更新发布 (实际的)

2019年5月28日

上次提交的符合 QC 标准的更新

2019年5月23日

最后验证

2018年7月1日

更多信息

与本研究相关的术语

其他研究编号

  • 2012.721
  • 2012-A00591-42 (其他标识符:ID-RCB)

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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