Recruiting

PoRSHA

Sponsor:

University of Chicago

Code:

NCT06551077

Conditions

Paraesophageal Hernia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

POSTERIOR RECTUS SHEATH HIATAL AUGMENTATION (PORSHA)

Study Details

Brief 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.

Conditions

Paraesophageal Hernia

Study ID

NCT06551077

Start date

May 15, 2024

Status verified date

Jan, 2026

Completion date

May, 2029

Anticipated

Primary completion date

May, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Interventions

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.

Primary outcome measure

  • Number of participants with recurrence of hernia as seen radiographically at routine esophagram [ Time Frame: At 6 months, 2 year and 5 years' time points ]

Central Contacts and Locations

Locations

The University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Principal Investigator:

Yalini Vigneswaran, MD, MPH

More Information

Sponsor

University of Chicago

Last update posted

Feb 2, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Chicago on 2026-02-02.