Recruiting

Biologic vs. Synthetic

Sponsor:

Stony Brook University

Code:

NCT02242526

Conditions

Hiatal Hernia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Parietex™ Composite Hiatal Mesh, North Haven, CT

Biodesign™ Surgisis® Graft, Cook Medical, Bloomington

Study Details

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.

Conditions

Hiatal Hernia

Study ID

NCT02242526

Start date

Sep, 2014

Status verified date

Oct, 2018

Completion date

Aug, 2020

Anticipated

Primary completion date

Sep, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

312 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: Parietex™ Composite Hiatal Mesh, North Haven, CT

Synthetic prosthetic mesh Parietex™ Composite Hiatal (PCO 2H) Mesh (Covidien, North Haven, CT) designed for hiatal hernia repair.

active comparator: Biodesign™ Surgisis® Graft, Cook Medical, Bloomington

Biologic mesh Biodesign™ Surgisis® Graft Reinforcement in Hiatal, Cook Medical, Bloomington, IN which will be placed for repair of hiatal hernia

Interventions

Parietex™ Composite Hiatal Mesh, North Haven, CT

Parietex™ Composite Hiatal Mesh (North Haven, CT) designed for hiatal hernia repair.

Biodesign™ Surgisis® Graft, Cook Medical, Bloomington

Biodesign™ Surgisis® Graft (Cook Medical, Bloomington) designed for hiatal hernia repair.

Primary outcome measure

  • Assess for reappearance of hiatal hernia and reflux [ Time Frame: 6 months, 60 months ]

Central Contacts and Locations

Locations

Stony Brook University Hospital

Recruiting

Stony Brook, New York, United States, 11794

Contacts

Aurora Pryor, MD

631-444-7788aurora.pryor@stonybrookmedicine.edu

Shabana Humayon, MD

6316380292shabana.humayon@stonybrookmedicine.edu

Principal Investigator:

Aurora Pryor, MD

More Information

Sponsor

Stony Brook University

Last update posted

Oct 15, 2018

Last verified

Oct, 2018

Keywords

  • hiatal hernia, recurrence, biologic mesh, synthetic mesh

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stony Brook University on 2018-10-15.