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
- Esophageal Hernia
- Hernia, Esophageal
- Hernia, Paraesophageal
- Hiatal Hernia
- Paraesophageal Hiatal Hernia
- Sliding Esophageal Hernia
- Sliding Hiatal Hernia
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.