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Trial record 1 of 1 for:    NCT02242526
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Biologic Versus Synthetic Mesh for Treatment of Paraesophageal Hernia

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ClinicalTrials.gov Identifier: NCT02242526
Recruitment Status : Recruiting
First Posted : September 17, 2014
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
Stony Brook University

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.

Condition or disease Intervention/treatment Phase
Hiatal Hernia Device: Parietex™ Composite Hiatal Mesh, North Haven, CT Device: Biodesign™ Surgisis® Graft, Cook Medical, Bloomington Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 312 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Biologic Versus Synthetic Mesh for Treatment of Paraesophageal Hernia
Study Start Date : September 2014
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Assess for reappearance of hiatal hernia and reflux [ 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.


Secondary Outcome Measures :
  1. Quality of Life questionnaire [ Time Frame: Quality of Life will be assessed at these time periods after the hernia repair 1, 6, 24, and 60 months ]
    Quality of life questionnaire containing 36 questions



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02242526


Locations
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United States, New York
Stony Brook University Hospital Recruiting
Stony Brook, New York, United States, 11794
Contact: Aurora Pryor, MD    631-444-7788    aurora.pryor@stonybrookmedicine.edu   
Contact: Shabana Humayon, MD    6316380292    shabana.humayon@stonybrookmedicine.edu   
Principal Investigator: Aurora Pryor, MD         
Sponsors and Collaborators
Stony Brook University

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Responsible Party: Stony Brook University
ClinicalTrials.gov Identifier: NCT02242526     History of Changes
Other Study ID Numbers: SB-568818
First Posted: September 17, 2014    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018

Keywords provided by Stony Brook University:
hiatal hernia, recurrence, biologic mesh, synthetic mesh

Additional relevant MeSH terms:
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Hernia
Hernia, Hiatal
Pathological Conditions, Anatomical
Hernia, Diaphragmatic