Use of Strattice Mesh in Paraesophageal Hernia Surgery
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.
Paraesophageal Hiatal Hernia
Sliding Esophageal Hernia
Sliding Hiatal Hernia
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Use of Strattice in the Laparoscopic Suture Closure of a Paraesophageal Hernia|
- Hernia recurrence [ Time Frame: 1 year post-surgery ] [ Designated as safety issue: No ]A barium swallow test with x-rays will be performed to assess recurrence of hernia, if any
- Recurrence of reflux symptoms [ Time Frame: 2 weeks, 6 months and 1 year post-surgery ] [ Designated as safety issue: No ]Patients will be evaluated for recurrence of reflux symptoms at the three postoperative visits. If recurrence warrants, a barium swallow with x-rays will be performed prior to 1-year primary outcome barium swallow test
|Study Start Date:||March 2012|
|Estimated Study Completion Date:||February 2014|
|Estimated Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
Documented symptomatic paraesophageal hernia
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.