N/A Completed N=4 Treatment

Efficacy Study to Evaluate Laparoscopic Fascial Closure Device

Hernia, Abdominal

Source: ClinicalTrials.gov NCT01024296 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2017

Primary outcomePrimary: Count of Participants With Successful Port Site Closure Using Port Close Device — 3 Participants

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.

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	—

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.

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.