Comparing mesh and sutures for paraesophageal hernia repair
A Randomized, Blinded, Parallel-group Trial Evaluating Mesh Versus Pledgeted Sutures in Paraesophageal Hernia Recurrence
This study is testing whether using a special mesh or stitches works better to prevent paraesophageal hernias from coming back after surgery for people who need this repair.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 164 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT05974722 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of Ovitex mesh versus pledgeted suture closure in reducing the recurrence of paraesophageal hernias over a two-year period. Conducted at the Cleveland Clinic, the study will enroll 164 patients who meet specific inclusion criteria and will be monitored for quality of life and recurrence rates post-surgery. The trial employs a randomized, single-blind design to minimize bias, with blinded outcome assessors evaluating the results. Participants will be followed for a total of seven years to assess long-term outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with Type II, III, or IV hiatal hernias greater than 5 cm.
Not a fit: Patients who are pregnant, have a BMI over 45, or have undergone previous hiatal hernia repairs may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced recurrence rates for patients undergoing paraesophageal hernia repair.
How similar studies have performed: Other studies have shown promising results with the use of mesh in hernia repairs, suggesting that this approach may be beneficial.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Cleveland, Ohio
- Cleveland Clinic Center for Abdominal Core Health — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: David M Krpata, MD — The Cleveland Clinic
- Study coordinator: David M Krpata, MD
- Email: krpatad@ccf.org
- Phone: 216 445-3441
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.