Mesh Vs Pledgets for Repair of Paraesophageal Hernia

Launched by MICHAEL ROSEN · Jul 26, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring the best way to repair a type of hernia called a paraesophageal hernia, which can cause symptoms like heartburn and difficulty swallowing. Researchers at the Cleveland Clinic want to find out if using a special mesh called Ovitex can help prevent the hernia from coming back after surgery, compared to a technique that uses stitches without mesh. They will also look at how these two methods affect patients' quality of life over two years.

To be part of this study, participants need to be at least 18 years old and be willing to attend follow-up visits and answer surveys. Eligible patients should have a specific type of hernia that is larger than 5 centimeters. However, those who are pregnant, have certain allergies, or have had previous hernia surgeries are not eligible. If you join the trial, you will receive either the mesh or the stitch repair during your hernia surgery, and you will help researchers learn more about the best treatment options for this condition.

Gender

ALL

Eligibility criteria

• 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