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RECRUITING
NCT06551077

Posterior Rectus Sheath Hiatal Augmentation in Paraesophageal Hernia Repair

Sponsor: University of Chicago

View on ClinicalTrials.gov

Summary

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.

Official title: Prospective Trial of Posterior Rectus Sheath Hiatal Augmentation (PORSHA) in Paraesophageal Hernia Repair

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2024-05-15

Completion Date

2029-05

Last Updated

2026-02-02

Healthy Volunteers

No

Interventions

PROCEDURE

POSTERIOR RECTUS SHEATH HIATAL AUGMENTATION (PORSHA)

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.

Locations (1)

The University of Chicago

Chicago, Illinois, United States