Biologic Versus Synthetic Mesh for Treatment of Paraesophageal Hernia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

312 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2020-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hiatal Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Parietex™ Composite Hiatal Mesh, North Haven, CT

Intervention Type DEVICE

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

Biodesign™ Surgisis® Graft, Cook Medical, Bloomington

Intervention Type DEVICE

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

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

Group Type ACTIVE_COMPARATOR

Parietex™ Composite Hiatal Mesh, North Haven, CT

Intervention Type DEVICE

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

Biodesign™ Surgisis® Graft, Cook Medical, Bloomington

Intervention Type DEVICE

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

Interventions

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Parietex™ Composite Hiatal Mesh, North Haven, CT

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

Intervention Type DEVICE

Biodesign™ Surgisis® Graft, Cook Medical, Bloomington

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes