Using a new technique to repair large paraesophageal hernias
Official title: Prospective Trial of Posterior Rectus Sheath Hiatal Augmentation (PORSHA) in Paraesophageal Hernia Repair
Run by University of Chicago · NCT06551077 · Data updated 2026-11-12
This study is testing a new surgical method for fixing large paraesophageal hernias in older patients to see if it works better and lasts longer than traditional repairs.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | University of Chicago Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Status | Recruiting |
| Started | May 15, 2024 |
| Main results expected | May 2029 |
| Study ends | May 2029 |
| Registry record updated | February 2, 2026 |
| Trial ID | NCT06551077 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are older patients with paraesophageal hernias measuring greater than 4 cm.
✕Probably not a fit
Patients who do not undergo PoRSHA or those with bleeding disorders may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study focuses on the use of a novel surgical technique called posterior rectus sheath flap hiatal augmentation (PoRSHA) for repairing challenging paraesophageal hernias in older patients. The approach utilizes the patient's own vascularized tissue to enhance the repair of the diaphragmatic hiatus, aiming to improve outcomes and durability compared to traditional methods. The study will observe patients undergoing this procedure to evaluate its effectiveness and safety in addressing large and recurrent hernias. The hypothesis is that PoRSHA can provide a stronger and more reliable repair than synthetic mesh or primary closure techniques.
Why it matters
Potential benefit: If successful, this technique could significantly improve surgical outcomes for patients with complex paraesophageal hernias.
How similar studies have gone: While this approach is innovative, it builds on existing techniques, and similar studies have shown promising outcomes with autologous tissue repairs.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * All patients undergoing PoRSHA. PoRSHA will be offered to all patients with PEH defects measuring greater than 4 cm. Exclusion Criteria: * Patients that did not have PoRSHA. * Patients requiring therapeutic anticoagulation perioperatively or those with bleeding disorders, considering the added risk of bleeding at the donor site with exposed rectus muscle.
Where it's running
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The University of Chicago
Chicago, Illinois, United States Recruiting
Study contacts
- Principal investigator: Yalini Vigneswaran, MD, MPH — University of Chicago
- Study coordinator: Yalini Vigneswaran
- Email: yvigneswaran@bsd.uchicago.edu
- Phone: 773-702-6337
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Removing the hernia sac to lower crural tension during paraesophageal hernia repair
This study will test whether taking out the hernia sac during paraesophageal hernia surgery lowers tension on the diaphragmatic crura in adults having repair for symptomatic paraesophageal hernia.
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Comparing two surgical methods for hiatal hernia repair
This study is testing which of two surgical methods for fixing hiatal hernias works better to prevent them from coming back and improve quality of life for patients.
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Repairing large hiatal hernias using Ovitex mesh
This study is testing if a special mesh can help fix large hiatal hernias and see if it keeps them from coming back while also checking how safe it is for patients.
-
Comparing mesh and sutures for paraesophageal hernia repair
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.
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Comparing sutures and polyglactin mesh for hiatal hernia repair
This study is testing whether using mesh instead of just stitches during surgery can help prevent paraesophageal hernias from coming back in patients.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.