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Biologic Versus Synthetic Mesh for Treatment of Paraesophageal Hernia

Primary Purpose

Hiatal Hernia

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Parietex™ Composite Hiatal Mesh, North Haven, CT
Biodesign™ Surgisis® Graft, Cook Medical, Bloomington
Sponsored by
Stony Brook University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hiatal Hernia focused on measuring hiatal hernia, recurrence, biologic mesh, synthetic mesh

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Stony Brook University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Parietex™ Composite Hiatal Mesh, North Haven, CT

Biodesign™ Surgisis® Graft, Cook Medical, Bloomington

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Quality of Life questionnaire
Quality of life questionnaire containing 36 questions

Full Information

First Posted
September 3, 2014
Last Updated
October 10, 2018
Sponsor
Stony Brook University
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1. Study Identification

Unique Protocol Identification Number
NCT02242526
Brief Title
Biologic Versus Synthetic Mesh for Treatment of Paraesophageal Hernia
Official Title
Biologic Versus Synthetic Mesh for Treatment of Paraesophageal Hernia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
September 2019 (Anticipated)
Study Completion Date
August 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stony Brook University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hiatal Hernia
Keywords
hiatal hernia, recurrence, biologic mesh, synthetic mesh

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
312 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Parietex™ Composite Hiatal Mesh, North Haven, CT
Arm Type
Active Comparator
Arm Description
Synthetic prosthetic mesh Parietex™ Composite Hiatal (PCO 2H) Mesh (Covidien, North Haven, CT) designed for hiatal hernia repair.
Arm Title
Biodesign™ Surgisis® Graft, Cook Medical, Bloomington
Arm Type
Active Comparator
Arm Description
Biologic mesh Biodesign™ Surgisis® Graft Reinforcement in Hiatal, Cook Medical, Bloomington, IN which will be placed for repair of hiatal hernia
Intervention Type
Device
Intervention Name(s)
Parietex™ Composite Hiatal Mesh, North Haven, CT
Intervention Description
Parietex™ Composite Hiatal Mesh (North Haven, CT) designed for hiatal hernia repair.
Intervention Type
Device
Intervention Name(s)
Biodesign™ Surgisis® Graft, Cook Medical, Bloomington
Intervention Description
Biodesign™ Surgisis® Graft (Cook Medical, Bloomington) designed for hiatal hernia repair.
Primary Outcome Measure Information:
Title
Assess for reappearance of hiatal hernia and reflux
Description
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.
Time Frame
6 months, 60 months
Secondary Outcome Measure Information:
Title
Quality of Life questionnaire
Description
Quality of life questionnaire containing 36 questions
Time Frame
Quality of Life will be assessed at these time periods after the hernia repair 1, 6, 24, and 60 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Stony Brook University Hospital
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aurora Pryor, MD
Phone
631-444-7788
Email
aurora.pryor@stonybrookmedicine.edu
First Name & Middle Initial & Last Name & Degree
Shabana Humayon, MD
Phone
6316380292
Email
shabana.humayon@stonybrookmedicine.edu
First Name & Middle Initial & Last Name & Degree
Aurora Pryor, MD

12. IPD Sharing Statement

Learn more about this trial

Biologic Versus Synthetic Mesh for Treatment of Paraesophageal Hernia

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