Biologic Versus Synthetic Mesh for Treatment of Paraesophageal Hernia

Study Overview
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Brief Summary
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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 modalities. The investigators hypothesize that use of synthetic mesh will have lower recurrence at these time points compared to use of biologic mesh.

Detailed Description
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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 months and at 60 months. Prior to and following laparoscopic paraesophageal hernia repair, patients will be followed with both subjective and objective measures. Subjective evaluation will include symptomatic/quality of life assessment at 1-, 6-, 24-, and 60- month periods; objective evaluation will include Upper GI study /pH probe study for symptomatic patients and for all patients at 6 and 60 months. The investigators hypothesize that use of synthetic mesh will have lower recurrence at these time points compared to use of biologic mesh.

Official Title
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Biologic Versus Synthetic Mesh for Treatment of Paraesophageal Hernia

Conditions
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Hiatal Hernia

Intervention / Treatment
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* Device: Parietex™ Composite Hiatal Mesh, North Haven, CT
* Device: Biodesign™ Surgisis® Graft, Cook Medical, Bloomington


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Parietex™ Composite Hiatal Mesh, North Haven, CT<br>Synthetic prosthetic mesh Parietex™ Composite Hiatal (PCO 2H) Mesh (Covidien, North Haven, CT) designed for hiatal hernia repair. | Device: Parietex™ Composite Hiatal Mesh, North Haven, CT<br>* Parietex™ Composite Hiatal Mesh (North Haven, CT) designed for hiatal hernia repair.<br>Device: Biodesign™ Surgisis® Graft, Cook Medical, Bloomington<br>* Biodesign™ Surgisis® Graft (Cook Medical, Bloomington) designed for hiatal hernia repair.<br>|
| Active Comparator: Biodesign™ Surgisis® Graft, Cook Medical, Bloomington<br>Biologic mesh Biodesign™ Surgisis® Graft Reinforcement in Hiatal, Cook Medical, Bloomington, IN which will be placed for repair of hiatal hernia | Device: Parietex™ Composite Hiatal Mesh, North Haven, CT<br>* Parietex™ Composite Hiatal Mesh (North Haven, CT) designed for hiatal hernia repair.<br>Device: Biodesign™ Surgisis® Graft, Cook Medical, Bloomington<br>* Biodesign™ Surgisis® Graft (Cook Medical, Bloomington) designed for hiatal hernia repair.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess for reappearance of hiatal hernia and reflux | Change at 6 and 60 months will be assessed by pH and Upper GI (endoscopy) studies to assess for reappearance of hiatal hernia and reflux. | 6 months, 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life questionnaire | Quality of life questionnaire containing 36 questions | Quality of Life will be assessed at these time periods after the hernia repair 1, 6, 24, and 60 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hiatal hernia, recurrence, biologic mesh, synthetic mesh