Efficacy Study to Evaluate Laparoscopic Fascial Closure Device
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 10/14/2017 |
| Start Date: | July 2009 |
| End Date: | March 2010 |
Pivotal Study to Evaluate the Efficacy of a Laparoscopic Port Closure Device
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.
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.
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).
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).
Inclusion Criteria:- Clinical Diagnosis of Morbid Obesity
- BMI > 40 or BMI > 35 with medical comorbidities
- Undergoing laparoscopic gastric surgery
- Have at least one trocar site measuring 12 mm or greater
Exclusion Criteria:Vulnerable subjects will be excluded including:
1. Children
2. Pregnant women
3. Economically and educationally disadvantaged
4. Decisionally impaired
5. Homeless people
6. Employees and students.
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