Biologic Versus Synthetic Mesh for Treatment of Paraesophageal Hernia

Stony Brook University

Status and phase: Unknown; Phase 4

Conditions: Hiatal Hernia

Treatments: Device: Biodesign™ Surgisis® Graft, Cook Medical, Bloomington; Device: Parietex™ Composite Hiatal Mesh, North Haven, CT

Study type: Interventional

Funder types: Other

Identifiers

NCT02242526

SB-568818

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 312 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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312 participants in 2 patient groups

Parietex™ Composite Hiatal Mesh, North Haven, CT

Active Comparator group

Description:

Synthetic prosthetic mesh Parietex™ Composite Hiatal (PCO 2H) Mesh (Covidien, North Haven, CT) designed for hiatal hernia repair.

Treatment:

Device: Biodesign™ Surgisis® Graft, Cook Medical, Bloomington

Device: Parietex™ Composite Hiatal Mesh, North Haven, CT

Biodesign™ Surgisis® Graft, Cook Medical, Bloomington

Active Comparator group

Description:

Biologic mesh Biodesign™ Surgisis® Graft Reinforcement in Hiatal, Cook Medical, Bloomington, IN which will be placed for repair of hiatal hernia

Treatment:

Device: Biodesign™ Surgisis® Graft, Cook Medical, Bloomington

Device: Parietex™ Composite Hiatal Mesh, North Haven, CT