Clinical Trial: Biologic Versus Synthetic Mesh for Treatment of Paraesophageal Hernia

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Biologic Versus Synthetic Mesh for Treatment of Paraesophageal Hernia

Brief 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 Summary: Patients will be randomized to either a synthetic (light weight synthetic or biologic (small intestinal submucosa [SIS]) 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 (UGI)/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.
Sponsor: Stony Brook University

Current Primary Outcome: Change [ Time Frame: 6 months, 60 months ]

Change at 6 and 60 months will be assessed by pH and Upper GI (endoscopy) studies to assess for reappearance of hiatal hernia and reflux.


Original Primary Outcome: Same as current

Current Secondary Outcome: Quality of Life [ Time Frame: 1, 6, 24, and 60 months ]

Quality of life questionnaire.


Original Secondary Outcome: Same as current

Information By: Stony Brook University

Dates:
Date Received: September 3, 2014
Date Started: September 2014
Date Completion: August 2020
Last Updated: October 13, 2016
Last Verified: October 2016