Biologic Versus Synthetic Mesh for Treatment of Paraesophageal Hernia

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02242526
Study type	Interventional
Source	Stony Brook University
Contact
Status	Recruiting
Phase	Phase 4
Start date	September 2014
Completion date	August 2020

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