Biologic Versus Synthetic Mesh for Treatment of Paraesophageal Hernia
1 other identifier
interventional
312
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2014
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 3, 2014
CompletedFirst Posted
Study publicly available on registry
September 17, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2020
CompletedOctober 15, 2018
October 1, 2018
5 years
September 3, 2014
October 10, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Quality of Life questionnaire
Quality of Life will be assessed at these time periods after the hernia repair 1, 6, 24, and 60 months
Study Arms (2)
Parietex™ Composite Hiatal Mesh, North Haven, CT
ACTIVE COMPARATORSynthetic prosthetic mesh Parietex™ Composite Hiatal (PCO 2H) Mesh (Covidien, North Haven, CT) designed for hiatal hernia repair.
Biodesign™ Surgisis® Graft, Cook Medical, Bloomington
ACTIVE COMPARATORBiologic 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) designed for hiatal hernia repair.
Biodesign™ Surgisis® Graft (Cook Medical, Bloomington) designed for hiatal hernia repair.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Stony Brook University Hospital
Stony Brook, New York, 11794, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 3, 2014
First Posted
September 17, 2014
Study Start
September 1, 2014
Primary Completion
September 1, 2019
Study Completion
August 1, 2020
Last Updated
October 15, 2018
Record last verified: 2018-10