Veritas Laparoscopic Paraesophageal Hiatal Hernia (PEH) Repair Pilot Trial
This is an investigator initiated pilot study to observe the short-term outcomes (a follow-up period of up to six months) of patients who undergo a laparoscopic paraesophageal Hiatal hernia (PEH) repair using the Veritas® Collagen Matrix brand biological mesh. This is a preliminary study at the University of Washington.
A PEH occurs when the stomach protrudes through the diaphragm next to the esophagus. The chance of recurrence of a Hiatal hernia after laparoscopic PEH repair is between 20-40% within 6 months.During laparoscopic PEH repair, a mesh-type product is used as a scaffold. The mesh serves as a reinforcing material during the surgical repair. It is cut to the appropriate size needed for the hernia and sutured to the surrounding diaphragmatic tissue. There are many different types of meshes available on the market, and vary in the degree of manageability, strength, and adherence.
Although surgical meshes work on the same principal, the variance between materials may affect patient outcomes. There is evidence that a biologic mesh, specifically one derived from Small Intestinal Submucosa (SIS), decreases the short-term (6-month) recurrence rates compared to a synthetic mesh or another type of biologic mesh. A biologic mesh, serving as a scaffold, will be replaced by the patient's own tissue after about 6 months. Theoretically, this would prevent the possible complications associated with synthetic mesh including mesh erosion into the esophagus or stricture of the esophagus.
There are some case series showing similar short-term results between the different biologic meshes, but there is no direct comparative data.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Veritas Laparoscopic PEH Repair Pilot Trial|
- Recurrence rate of Hiatal Hernia rate based on UGI series [ Time Frame: Pre-operative, procedure and 6-months ] [ Designated as safety issue: No ]
- Pre and Post-operative symptoms and Quality of Life Assessments [ Time Frame: pre-operative visit and at 6 months post-op ] [ Designated as safety issue: No ]SF-36v2, "Your health and well being"
|Study Start Date:||May 2010|
|Study Completion Date:||December 2013|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Device: Veritas® Collagen Matrix
Please refer to this study by its ClinicalTrials.gov identifier: NCT01195545
|United States, Washington|
|University of Washington|
|Seattle, Washington, United States, 98195|
|Principal Investigator:||Brant K. Oelschlager, M.D.||University of Washington|