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
  Purpose

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.


Condition Intervention
Hernia, Abdominal
Device: Closing Port Site

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pivotal Study to Evaluate the Efficacy of a Laparoscopic Port Closure Device

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Closure of Port Site [ Time Frame: 1 Day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety of closure device [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 5
Study Start Date: May 2009
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
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).

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01024296

Contacts
Contact: Bilal M Shafi, MD (215) 738-0400 bmshafi@stanford.edu

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Bilal M Shafi, MD    215-738-0400    bmshafi@stanford.edu   
Principal Investigator: Thomas M. Krummel         
Principal Investigator: John Morton         
Sponsors and Collaborators
Stanford University
SurgSolutions, LLC
Investigators
Principal Investigator: Thomas M. Krummel Stanford University
  More Information

No publications provided

Responsible Party: Thomas M. Krummel, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT01024296     History of Changes
Other Study ID Numbers: SU-11062009-4361, IRB Protocol #8864
Study First Received: November 13, 2009
Last Updated: December 11, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hernia
Hernia, Abdominal
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 28, 2014