Actively Recruiting
Prospective Trial of Posterior Rectus Sheath Hiatal Augmentation (PoRSHA) in Paraesophageal Hernia Repair
Led by University of Chicago · Updated on 2026-02-02
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to observe the use of Posterior Rectus Sheath Hiatal Augmentation (PoRSHA) in patients with large and complex paraesophageal hernias (PEH), especially in older adults. PEH repair is challenging due to weakened diaphragmatic muscles and the risks associated with synthetic mesh. PoRSHA uses the patient's own vascularized fascia to strengthen the hiatal repair and improve durability, potentially offering advantages over current repair methods. The study follows the IDEAL framework for surgical innovation to assess long-term outcomes in a larger patient group. The intervention involves using a novel permanent autologous vascularized biologic fascial flap to reconstruct the diaphragmatic hiatus following standard hiatal hernia repair. PoRSHA is performed for large (type III and IV) and recurrent PEHs where the hernia defect measures greater than 4 cm. This technique aims to enhance the hiatal repair by adding strength with the patient's own tissue rather than synthetic mesh. Participants will be monitored over time with routine esophagram imaging at 6 months, 2 years, and 5 years to check for hernia recurrence. Researchers will also evaluate symptom relief, use of anti-acid medications, presence of swallowing difficulties, and any abdominal wall deformities or symptoms at these time points. The study involves long-term follow-up to better understand the safety and effectiveness of PoRSHA in a larger population.
CONDITIONS
Brief Title
Posterior Rectus Sheath Hiatal Augmentation in Paraesophageal Hernia Repair
Who Can Participate
Eligibility Criteria
You may qualify if you...
- All patients undergoing PoRSHA
- PoRSHA offered to patients with paraesophageal hernia defects larger than 4 cm
You will not qualify if you...
- Patients who did not have PoRSHA
- Patients requiring therapeutic anticoagulation during surgery or with bleeding disorders due to bleeding risk at the donor site
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day and initial hospital recovery period
Participants undergo paraesophageal hernia repair with posterior rectus sheath hiatal augmentation (PoRSHA), a surgical technique to reconstruct the diaphragmatic hiatus using the patient's own vascularized fascia.
1 surgical procedure and hospitalization
Duration - Up to 5 years
Participants are monitored for recovery, symptom relief, and potential complications such as dysphagia or abdominal wall issues following surgery.
Follow-up visits at 6 months, 2 years, and 5 years
Trial Site Locations
Total: 1 location
1
The University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
Research Team
Y
Yalini Vigneswaran
H
Hira Khan
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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