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Mesh Vs Pledgets for Repair of Paraesophageal Hernia

RecruitingNAAges 18 Years - anyAllDavid Krpata
NCT05974722 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to compare whether the use of Ovitex mesh provides superior reduction in 2-year recurrence compared to pledgeted suture closure (no mesh) for patients undergoing paraesophageal hernia repair at the Cleveland Clinic. The main questions it aims to answer are: * Determine whether there is a difference in 2-year rates of radiographic recurrence with Ovitex versus pledgeted sutures in paraesophageal hernia repair. * Assess patient quality of life (QOL) after paraesophageal hernia repair with pledgets and mesh. A two-tailed research hypothesis will be used to determine whether there are differences between the two arms

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📋 Eligibility rules (as published)
Inclusion Criteria: * 18 years of age or older * Willing and able to provide informed consent * Willing and able to participate in long-term follow up including study visits and surveys * Type II, III, or IV hiatal hernia \> 5 cm, confirmed via upper GI studies, CT, or MRI 5 cm or greater hernia confirmed intraoperatively Exclusion Criteria: * Pregnancy * BMI \>45 * Allergy to any components of mesh * Patients undergoing PEHR with a concurrent bariatric procedure or other procedure to reduce stomach volume (sleeve gastrectomy, roux-en-y gastric bypass, duodenal switch, single-anastomosis gastric bypass, and partial or total gastrectomy) * Patients who have undergone previous hiatal hernia repair
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What it tests

  • OviTex Mesh
  • Pledgeted sutures
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Where

1 site
Cleveland Clinic Center for Abdominal Core Health
Cleveland, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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