NCT02242526

Biologic Versus Synthetic Mesh for Treatment of Paraesophageal Hernia

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 312 (estimated)
• Sponsor: Stony Brook University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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 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

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.

Conditions

• Hiatal Hernia

Interventions

Type	Name	Description
DEVICE	Parietex™ Composite Hiatal Mesh, North Haven, CT	Parietex™ Composite Hiatal Mesh (North Haven, CT) designed for hiatal hernia repair.
DEVICE	Biodesign™ Surgisis® Graft, Cook Medical, Bloomington	Biodesign™ Surgisis® Graft (Cook Medical, Bloomington) designed for hiatal hernia repair.

Timeline

• Start date: 2014-09-01
• Primary completion: 2019-09-01
• Completion: 2020-08-01
• First posted: 2014-09-17
• Last updated: 2018-10-15

Locations

1 site across 1 country: United States