N/A
N=4
Efficacy Study to Evaluate Laparoscopic Fascial Closure Device
Hernia, Abdominal
Bottom Line
View on ClinicalTrials.gov: NCT01024296 ↗Enrolled (actual)
4
Serious AEs
0.0%
Results posted
Oct 2017
Primary outcome: Primary: Count of Participants With Successful Port Site Closure Using Port Close Device — 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Port Close (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Count of Participants With Successful Port Site Closure Using Port Close Device |
3 | — |
| PRIMARY Time of Port Site Closure |
138.7 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01024296). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.