Biologic Versus Synthetic Mesh for Treatment of Paraesophageal Hernia

Status unconfirmed · Phase 4

Conditions studied: Hiatal Hernia

In brief

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.

Key facts

Study ID

NCT02242526

Run by

Stony Brook University

People needed

312

Starts

2014-09-01

Expected to finish

2020-08-01

Last updated by the study team

2018-10-15

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Stony Brook University Hospital — Stony Brook, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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