Use of Strattice Mesh in Paraesophageal Hernia Surgery

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.

Inclusion Criteria:

- Documented symptomatic paraesophageal hernia.

- Greater than 5 cm hiatal hernia on upper gastrointestinal study.

- Evidence that the stomach or other viscera is present in the hernia and does not
spontaneously reduce from the mediastinum.

- Significant symptoms or signs of a paraesophageal hernia including but not limited to
heartburn, dysphagia, chest pain, shortness of breath, postprandial abdominal pain,
early satiety, odynophagia, or chronic anemia.

- Consenting adult 19 years of age or older

- Must be able to participate in follow-up evaluation.

- Free of cognitive impairment

Exclusion Criteria:

- Children and adolescents (19 years of age or younger).

- Pregnant and breast feeding patients.

- Vulnerable subjects such as pregnant women, children less than 19 years age, and
decisionally impaired persons.

- Patients with previous operation of the esophagus or stomach.

- Patients with associated gastrointestinal diseases that require extensive medical or
surgical intervention that might interfere with quality of life assessment (e.g.
Crohn's disease).

- Patients with emergent operation for acute gastric volvulus.

- Patients with known sensitivity to porcine material.