Efficacy Study to Evaluate Laparoscopic Fascial Closure Device

• Sponsor: Stanford University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01024296
• Collaborator: SurgSolutions, LLC (Industry)
• Enrollment: 4
• Location: 1
• Arm: 1
• Actual Duration (Months): 8
• Patients Per Site Per Month: 0.5

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
Hernia, Abdominal	Device: Port Close	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

• Study Type: Interventional
• Actual Enrollment: 4 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pivotal Study to Evaluate the Efficacy of a Laparoscopic Port Closure Device
• Actual Study Start Date: Jul 1, 2009
• Actual Primary Completion Date: Mar 1, 2010
• Actual Study Completion Date: Mar 1, 2010

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

1. Count of Participants With Successful Port Site Closure Using Port Close Device [Day 1, at the end of surgery]

2. Time of Port Site Closure [Day 1, from insertion to removal of Port Close device during surgery]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

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.

• Responsible Party: Thomas Krummel, Principle Investigator, Stanford University
• ClinicalTrials.gov Identifier: NCT01024296
• Other Study ID Numbers: SU-11062009-4361; IRB Protocol #8864
• First Posted: Dec 2, 2009
• Last Update Posted: Oct 12, 2017
• Last Verified: Sep 1, 2017

• Additional relevant MeSH terms: Hernia, Abdominal; Internal Hernia

Study Results

Participant Flow

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

1. Primary Outcome

Title	Count of Participants With Successful Port Site Closure Using Port Close Device
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%

2. Primary Outcome

Title	Time of Port Site Closure
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

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

[Not Specified]

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.