Clinical trial NCT01678157: Use of Strattice Mesh in Paraesophageal Hernia Surgery
Official title: Use of Strattice in the Laparoscopic Suture Closure of a Paraesophageal Hernia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophageal Hernia
Hernia, Esophageal
Hernia, Paraesophageal
Hiatal Hernia
Paraesophageal Hiatal Hernia
Sliding Esophageal Hernia
Sliding Hiatal Hernia
Keywords: Esophageal Hernia
Hernia, Esophageal
Hernia, Paraesophageal
Hiatal Hernia
Paraesophageal Hiatal Hernia
Sliding Esophageal Hernia
Sliding Hiatal Hernia
Lead sponsor: University of Nebraska
Sponsor class: OTHER
Collaborators: name: LifeCell
First posted: 2012-09-03
Enrollment: 35
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults over 19 years of age with paraesophageal hernia greater than 5 cm.

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Hernia recurrence
timeFrame: 1 year post-surgery
Secondary outcomes:
measure: Recurrence of reflux symptoms
timeFrame: 2 weeks, 6 months and 1 year post-surgery
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Dmitry Oleynikov, MD
role: PRINCIPAL_INVESTIGATOR
References: