Biologic Versus Synthetic Mesh for Treatment of Paraesophageal Hernia

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.

Study Overview

• Status: Unknown
• Conditions: Hiatal Hernia
• Intervention / Treatment: Device: Parietex™ Composite Hiatal Mesh, North Haven, CT; Device: Biodesign™ Surgisis® Graft, Cook Medical, Bloomington

Detailed 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 Type: Interventional
• Enrollment (Anticipated): 312
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • Stony Brook, New York, United States, 11794
      • Recruiting
      • Stony Brook University Hospital
      • Contact: Aurora Pryor, MD; Phone Number: 631-444-7788; Email: aurora.pryor@stonybrookmedicine.edu
      • Contact: Shabana Humayon, MD; Phone Number: 6316380292; Email: shabana.humayon@stonybrookmedicine.edu
      • Principal Investigator: Aurora Pryor, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: Parietex™ Composite Hiatal Mesh, North Haven, CT; Parietex™ Composite Hiatal Mesh (North Haven, CT) designed for hiatal hernia repair.; Device: Biodesign™ Surgisis® Graft, Cook Medical, Bloomington; Biodesign™ Surgisis® Graft (Cook Medical, Bloomington) 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	Device: Parietex™ Composite Hiatal Mesh, North Haven, CT; Parietex™ Composite Hiatal Mesh (North Haven, CT) designed for hiatal hernia repair.; Device: Biodesign™ Surgisis® Graft, Cook Medical, Bloomington; Biodesign™ Surgisis® Graft (Cook Medical, Bloomington) designed for hiatal hernia repair.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess for reappearance of hiatal hernia and reflux	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.	6 months, 60 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life questionnaire	Quality of life questionnaire containing 36 questions	Quality of Life will be assessed at these time periods after the hernia repair 1, 6, 24, and 60 months

Collaborators and Investigators

• Sponsor: Stony Brook University

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Anticipated): September 1, 2019
• Study Completion (Anticipated): August 1, 2020

Study Registration Dates

• First Submitted: September 3, 2014
• First Submitted That Met QC Criteria: September 15, 2014
• First Posted (Estimate): September 17, 2014

Study Record Updates

• Last Update Posted (Actual): October 15, 2018
• Last Update Submitted That Met QC Criteria: October 10, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: hiatal hernia, recurrence, biologic mesh, synthetic mesh
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Diaphragmatic; Internal Hernia; Hernia; Hernia, Hiatal
• Other Study ID Numbers: SB-568818