Efficacy Study to Evaluate Laparoscopic Fascial Closure Device
Study Details
Study Description
Brief 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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
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 Design
Arms and Interventions
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
|
Outcome Measures
Primary Outcome Measures
- 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]
Eligibility Criteria
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:
-
Children
-
Pregnant women
-
Economically and educationally disadvantaged
-
Decisionally impaired
-
Homeless people
-
Employees and students.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Stanford University School of Medicine | Stanford | California | United States | 94305 |
Sponsors and Collaborators
- Stanford University
- SurgSolutions, LLC
Investigators
- Principal Investigator: Thomas M. Krummel, Stanford University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SU-11062009-4361
- IRB Protocol #8864
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Gastric Bypass Surgery Patients |
---|---|
Arm/Group Description | Port Close: Device for applying loop suture to close surgical site |
Period Title: Overall Study | |
STARTED | 4 |
COMPLETED | 4 |
NOT COMPLETED | 0 |
Baseline Characteristics
Arm/Group Title | Gastric Bypass Surgery Patients |
---|---|
Arm/Group Description | Port Close: Device for applying loop suture to close surgical site |
Overall Participants | 4 |
Age (Count of Participants) | |
<=18 years |
0
0%
|
Between 18 and 65 years |
4
100%
|
>=65 years |
0
0%
|
Sex: Female, Male (Count of Participants) | |
Female |
4
100%
|
Male |
0
0%
|
Outcome Measures
Title | Count of Participants With Successful Port Site Closure Using Port Close Device |
---|---|
Description | |
Time Frame | Day 1, at the end of surgery |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Gastric Bypass Surgery Patients |
---|---|
Arm/Group Description | Port Close: Device for applying loop suture to close surgical site |
Measure Participants | 4 |
Count of Participants [Participants] |
3
75%
|
Title | Time of Port Site Closure |
---|---|
Description | |
Time Frame | Day 1, from insertion to removal of Port Close device during surgery |
Outcome Measure Data
Analysis Population Description |
---|
Participants with successful closure using the Port Close device were included in the analysis. |
Arm/Group Title | Gastric Bypass Surgery Patients |
---|---|
Arm/Group Description | Port Close: Device for applying loop suture to close surgical site |
Measure Participants | 3 |
Mean (Standard Deviation) [seconds] |
138.7
(22.21)
|
Adverse Events
Time Frame | ||
---|---|---|
Adverse Event Reporting Description | ||
Arm/Group Title | Gastric Bypass Surgery Patients | |
Arm/Group Description | Port Close: Device for applying loop suture to close surgical site | |
All Cause Mortality |
||
Gastric Bypass Surgery Patients | ||
Affected / at Risk (%) | # Events | |
Total | / (NaN) | |
Serious Adverse Events |
||
Gastric Bypass Surgery Patients | ||
Affected / at Risk (%) | # Events | |
Total | 0/4 (0%) | |
Other (Not Including Serious) Adverse Events |
||
Gastric Bypass Surgery Patients | ||
Affected / at Risk (%) | # Events | |
Total | 0/4 (0%) |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Bilal M Shafi, MD |
---|---|
Organization | Stanford University |
Phone | (215) 738-0400 |
bmshafi@stanford.edu |
- SU-11062009-4361
- IRB Protocol #8864