UnknownPhase 4

Biologic Versus Synthetic Mesh for Treatment of Paraesophageal Hernia

United States312 participantsStarted 2014-09

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Assess for reappearance of hiatal hernia and reflux

Timeframe: 6 months, 60 months

Trial details

NCT IDNCT02242526

SponsorStony Brook University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-09

View on ClinicalTrials.gov More Hiatal Hernia trials