Efficacy Study to Evaluate Laparoscopic Fascial Closure Device
Condition: Hernia, Abdominal
MeSH terms: Hernia, Abdominal; Internal Hernia
Study type: Interventional

Summary: 
      During any minimally invasive surgery case, 5-25mm size incisions need to be made to gain
      access to the abdomen. One of the most difficult, time-consuming, and sometimes unreliable
      parts of the case is closing these incisions, especially in obese patients. This is mainly
      because these incisions are very small and the layer that needs to be closed (fascia) rests
      deep underneath the skin and fat tissue of the abdominal wall. Two of the investigators (CM
      and BS) have developed at Stanford an instrument that allows for an easier and more reliable
      closure of these wounds. The purpose of this study is to test this instrument in the closure
      of laparoscopic wounds in obese patients undergoing laparoscopic gastric bypass surgery.
    

Detailed description: 
      For the patients enrolling in this study, preoperative and postoperative care will be exactly
      the same. The operative procedure will also be very similar with the only modification being
      in the way the ports are closed at the end of the surgery and the fact that all ports 11mm or
      greater will be closed (instead of leaving 11 or 12mm ports to be closed at the discretion of
      the surgeon). Instead of using a suture-passer to place the suture through the fascia, the
      surgeon will use the new instrument to drive the suture into the tissue under direct
      visualization through the umbilical port camera. The same instrument but with new sutures
      will be used for each of the interrupted stitches that are usually placed to close the port.

      The instrument that has been developed by some of the investigators is a 10mm elongated
      device that can easily be inserted into the port or fascial opening. If inserted through the
      port, the trocar can then be slid over the instrument to remove the trocar without losing
      pneumoperitoneum. The instrument has two opposing wings that will open once placed beyond the
      fascial opening. As the surgeon pulls up on the device, the wings open sliding along the
      fascia and pushing away any intra-abdominal contents that may be close to the instrument.
      Once the surgeon assures under direct visualization with the camera that the wings are open
      at both sides of the wound and that all intra-abdominal contents are out of the way (just as
      the surgeon would with the standard technique), he or she pushes a plunger that drives two
      flexible nitinol needles from the shaft of the instrument, through the fascia, and into the
      wings. The needles will be received in the wings by a set of couplers attached to the same
      suture that would be used otherwise (#0 Vycril). The surgeon then releases the wings and
      pulls out the device, leaving a looped suture placed around the opening. The surgeon can then
      tie the sutures as he or she would normally do on the standard procedure. At any time, the
      surgeon can reposition or remove the instrument without placing the sutures. The procedure
      may be repeated as many times as the surgeon considers necessary (usually 1 to close the 11
      or 12mm fascial ports and 2 or 3 to close the 25mm fascial port).
    

Intervention name(s): Port Close
Intervention type(s): Device
Intervention description(s): Device for applying loop suture to close surgical site
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment