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Efficacy Study to Evaluate Laparoscopic Fascial Closure Device

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Stanford University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
SurgSolutions, LLC
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT01024296
First received: November 13, 2009
Last updated: December 11, 2009
Last verified: December 2009

November 13, 2009
December 11, 2009
May 2009
March 2010   (final data collection date for primary outcome measure)
Closure of Port Site [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01024296 on ClinicalTrials.gov Archive Site
Safety of closure device [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Efficacy Study to Evaluate Laparoscopic Fascial Closure Device
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.

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).

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hernia, Abdominal
Device: Closing Port Site
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
5
March 2010
March 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
Yes
Contact: Bilal M Shafi, MD (215) 738-0400 bmshafi@stanford.edu
United States
 
NCT01024296
SU-11062009-4361, IRB Protocol #8864
Not Provided
Thomas M. Krummel, Stanford University School of Medicine
Stanford University
SurgSolutions, LLC
Principal Investigator: Thomas M. Krummel Stanford University
Stanford University
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP