Clinical Trials Directory

Trials / Completed

CompletedNCT01678157

Use of Strattice Mesh in Paraesophageal Hernia Surgery

Use of Strattice in the Laparoscopic Suture Closure of a Paraesophageal Hernia

Status
Completed
Phase
Study type
Observational
Enrollment
35 (actual)
Sponsor
University of Nebraska · Academic / Other
Sex
All
Age
19 Years
Healthy volunteers
Not accepted

Summary

The objective of this study is to examine the safety and efficacy of porcine acellular dermal matrix mesh (Strattice; LifeCell Corp., Branchburg, NJ) in crural reinforcement of laparoscopic large paraesophageal hernia repair.

Detailed description

Prosthetic reinforcements reduce recurrence rates; the choice of optimal prosthetic, either synthetic or biosynthetic, for crural reinforcement is controversial. The objective of this study is to examine the safety and efficacy of porcine acellular dermal matrix mesh (Strattice; LifeCell Corp., Branchburg, NJ) in crural reinforcement of laparoscopic large paraesophageal hernia repair. Strattice is a commonly used mesh in hernia repair. 35 adult (\>19 years of age) patients will be selected based on inclusion and exclusion criteria. Patients who meet the criteria will be enrolled in the study. Information related to recurrence rates based on follow-up visits will be analyzed to determine the efficacy of Strattice in the prevention of large hernia recurrence.

Conditions

Timeline

Start date
2012-03-05
Primary completion
2015-05-01
Completion
2015-05-01
First posted
2012-09-03
Last updated
2023-09-06

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01678157. Inclusion in this directory is not an endorsement.