Actively Recruiting

Age: 18Years +
All Genders
NCT06551077

Posterior Rectus Sheath Hiatal Augmentation in Paraesophageal Hernia Repair

Led by University of Chicago · Updated on 2026-02-02

100

Participants Needed

1

Research Sites

258 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study will be a prospective observation study of the use of PoRSHA for repair in patients with challenging paraesophageal hernias. One of the most challenging problems facing foregut surgeons is the large and complex paraesophageal hernia (PEH) repair in the older patient. The investigator has demonstrated good outcomes and durability with the initial use of a novel permanent autologous vascularized biologic fascial flap to reconstruct the diaphragmatic hiatus following standard hiatal hernia repair in selected patients. This technique is called a posterior rectus sheath flap hiatal augmentation or PoRSHA, which is performed to enhance the hiatal repair for large (type III and IV) and recurrent PEH. The investigator believes by using the patient's autologous vascularized and peritonealized fascia at the hiatal defect, PoRSHA could increase the strength and restore the hiatal complex properties in ways that synthetic mesh, or a primary repair cannot. The hypothesis is that PoRSHA is a unique technique that has the potential to supplant current approaches to primary hiatal closure in select cases. By augmenting the hiatal closure with a vascularized fascial sheath, PoRSHA provides the tensile strength needed for the attenuated defects in large and complex PEHs.

CONDITIONS

Official Title

Posterior Rectus Sheath Hiatal Augmentation in Paraesophageal Hernia Repair

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients undergoing PoRSHA surgery
  • Paraesophageal hernia defects greater than 4 cm
Not Eligible

You will not qualify if you...

  • Patients not undergoing PoRSHA surgery
  • Patients requiring therapeutic anticoagulation during surgery or with bleeding disorders due to bleeding risks at the donor site

AI-Screening

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Trial Site Locations

Total: 1 location

1

The University of Chicago

Chicago, Illinois, United States, 60637

Actively Recruiting

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Research Team

Y

Yalini Vigneswaran

CONTACT

H

Hira Khan

CONTACT

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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