Transmitted Light Tissue Thickness Analysis (TiLTT)
Condition: Morbid Obesity
MeSH terms: Obesity, Morbid
Study type: Interventional

Summary: 
      To assess gastric wall thickness using transmitted light intensity.
    

Detailed description: 
      The most common surgical procedure for weight loss is the sleeve gastrectomy. The
      laparoscopic sleeve gastrectomy (LSG) involves the linear stapling of the stomach using a
      stapling device [e.g. Echelon (Ethicon Somerset NJ)] fired multiple times along the length of
      the stomach thereby excising 80-90% of the stomach leaving the patient with a "sleeve" of
      stomach rather than the normal anatomical pouch. The gastric wall varies in thickness and
      thus there are a varied staple sizes available for this use. Staple sizes range from
      2.0mm-5.0mm in height. In standard surgical practice the surgeon chooses the size of staple
      cartridge for each subsequent firing based on his experience and estimations about the
      thickness of the stomach tissue in any given region. The drawback of this technique is that
      it is highly inaccurate. If the surgeon's estimation is in error, the staple height chosen
      may be either too tall or too short leading to bleeding or leakage from between the staples
      or malformed/unformed staples leading to staple line failure. Any of these errors can lead to
      devastating complications such as hemorrhage, leak, sepsis and death. To date there is no
      objective way to measure the thickness of the tissue being stapled and thus staple choice
      relies entirely on surgeon estimation which is inherently inaccurate. The investigators
      hypothesize that a light source placed in the stomach lumen will transmit light through the
      gastric wall. The amount of light transmitted, i.e. visible to an imaging device arrayed
      external to the stomach, will be directly proportionate to the thickness of the stomach. This
      study will take advantage of the fact that during routine procedures in the sleeve
      gastrectomy procedure a lighted tube is placed into the gastric lumen via the mouth. This
      device is called the Gastrisail and has 10 separate LED lights arrayed along its length. This
      allows for the measurement of transmitted light intensity through the gastric wall at 10
      individual locations along the length f the stomach. In addition this study will take
      advantage of the fact that during standard practice in a sleeve gastrectomy a section of the
      stomach corresponding to the location of the lights is excised and sent for pathological
      evaluation. This will allow us to measure the actual thickness of the stomach at 10 points
      corresponding to he locations of the transmitted light intensity. For this measurement The
      investigators will use a standardized and validated measurement tool/calipers. Now with two
      sets of numbers the investigators plan to correlate the degree of transmitted light intensity
      with actual thickness measurements and thereby reach an algorithm which will allow the
      transmitted light intensity data alone to predict gastric wall thickness. This will provide
      the surgeon with an entirely non-invasive objective measure of gastric wall thickness and
      hopefully improve his/her choice of staple size during these surgical procedures thus
      improving safety.
    

Intervention name(s): Gastrisail
Intervention type(s): Device
Intervention description(s): Light Intensity and gastric wall thickness assessment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Obesity; sleeve gastrectomy