Status:
UNKNOWN
Biologic Versus Synthetic Mesh for Treatment of Paraesophageal Hernia
Lead Sponsor:
Stony Brook University
Conditions:
Hiatal Hernia
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
The investigators propose a randomized, single blinded controlled trial to compare the use of synthetic versus biologic mesh in hiatal hernia repair, two currently accepted standard of care surgical m...
Detailed Description
Patients will be randomized to either a synthetic (light weight synthetic or biologic (small intestinal submucosa ) mesh group. Endpoints will be measured up to 5 years for the study as a whole, at 6 ...
Eligibility Criteria
Inclusion
- Male or female gender
- Age\>18 years
- Absence of chronic medical conditions that will affect the quality of life survey, such as fibromyalgia, SLE, Crohn's disease, etc.
- Able to give informed consent
- Able and willing to participate in follow-up evaluations
- Upper GI with a documented hiatal hernia greater than 5cm
- Paraesophageal hernia with clinically relevant symptoms such as heartburn, chest pain, regurgitation, dysphagia, postprandial abdominal pain, shortness of breath, or early satiety.
Exclusion
- Previous surgery of the esophagus and/or the stomach
- Emergent operation for acute gastric volvulus or strangulation
- Biopsy consistent with malignancy
- Body Mass Index (BMI) over 35kg/m2
- Inability to perform primary closure of crura
- Active smoking
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2020
Estimated Enrollment :
312 Patients enrolled
Trial Details
Trial ID
NCT02242526
Start Date
September 1 2014
End Date
August 1 2020
Last Update
October 15 2018
Active Locations (1)
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1
Stony Brook University Hospital
Stony Brook, New York, United States, 11794