Veritas Laparoscopic Paraesophageal Hiatal Hernia (PEH) Repair Pilot Trial
Hiatal Hernia
About this trial
This is an interventional treatment trial for Hiatal Hernia focused on measuring Veritas® Collagen Matrix, Hiatal hernia
Eligibility Criteria
Inclusion Criteria:
A. Subjects must have a documented symptomatic paraesophageal hernia that:
- 1. Is greater than 5 cm hiatal hernia on Upper Gastrointestinal (UGI) series
- 2. Has evidence that the stomach or other viscera is present in the hernia and does not spontaneously reduce from the mediastinum
- 3. Has significant symptoms or signs of a paraesophageal hernia: heartburn, dysphagia, chest pain, shortness of breath, post-prandial abdominal pain, early satiety, odynophagia or chronic anemia
B. Consenting adult ≥18 years ~ documentation of informed consent will be recorded in the research records
C. Must be able to participate in follow-up evaluations (subjects must be fully cognitive)
D. Has a telephone
E. Free of cognitive or speech impairment
Exclusion Criteria:
A. Previous operation of the esophagus or stomach
B. Associated gastrointestinal diseases that require extensive medical or surgical intervention that might interfere with quality of life assessment (e.g. Crohn's disease)
C. Emergent operation for acute volvulus (twisting/rotation of the bowel leading to obstruction)
Sites / Locations
- University of Washington
Arms of the Study
Arm 1
Experimental
Veritas Mesh in Hernia Repair
Subjects undergoing laparoscopic paraesophageal hiatal hernia repair using a bovine pericardium mesh (BP) (Veritas® Collagen Matrix, Synovis ®, St. Paul MN) as a reinforcing material during repair.