Biologic Versus Synthetic Mesh for Treatment of Paraesophageal Hernia
| Status: | Recruiting |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 10/17/2018 |
| Start Date: | September 2014 |
| End Date: | August 2020 |
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.
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.
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.
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.
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
We found this trial at
1
site
Stony Brook, New York 11794
Principal Investigator: Aurora Pryor, MD
Phone: 631-444-7788
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