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.

Study Overview

• Status: Completed
• Conditions: Hernia, Abdominal
• Intervention / Treatment: Device: Port Close

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).

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gastric Bypass Surgery Patients; Surgical site closure using Port Close device	Device: Port Close; Device for applying loop suture to close surgical site

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Count of Participants With Successful Port Site Closure Using Port Close Device	Day 1, at the end of surgery
Time of Port Site Closure	Day 1, from insertion to removal of Port Close device during surgery

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: SurgSolutions, LLC
• Investigators: Principal Investigator: Thomas M. Krummel, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2009
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: November 13, 2009
• First Submitted That Met QC Criteria: November 30, 2009
• First Posted (Estimate): December 2, 2009

Study Record Updates

• Last Update Posted (Actual): October 12, 2017
• Last Update Submitted That Met QC Criteria: September 15, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia; Hernia, Abdominal; Internal Hernia
• Other Study ID Numbers: SU-11062009-4361; IRB Protocol #8864 (Other Identifier: Stanford University)