Use of Strattice Mesh in Paraesophageal Hernia Surgery (NCT01678157) | Clinical Trial Compass
CompletedNot Applicable
Use of Strattice Mesh in Paraesophageal Hernia Surgery
United States35 participantsStarted 2012-03-05
Plain-language 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.
Who can participate
Age range19 Years
SexALL
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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.