Using a new technique to repair large paraesophageal hernias
Prospective Trial of Posterior Rectus Sheath Hiatal Augmentation (PORSHA) in Paraesophageal Hernia Repair
University of Chicago · NCT06551077
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 |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Chicago (other) |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT06551077 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are older patients with paraesophageal hernias measuring greater than 4 cm.
Not a fit: Patients who do not undergo PoRSHA or those with bleeding disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this technique could significantly improve surgical outcomes for patients with complex paraesophageal hernias.
How similar studies have performed: While this approach is innovative, it builds on existing techniques, and similar studies have shown promising outcomes with autologous tissue repairs.
Eligibility criteria
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 this trial is running
Chicago, Illinois
- 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
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.
Conditions: Paraesophageal Hernia