Gastric Volumetry by Gastric Tomodensitometry With Gas
Condition: Morbid Obesity
MeSH terms: Obesity, Morbid
Study type: Interventional

Summary: 
      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.
    


Intervention name(s): gastric tomodensitometry with gas at 3 months and 12 months
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: obesity, sleeve gastrectomy, gastric bypass, gastric tomodensitometry, gastric pouch size, weight regain