Posterior Rectus Sheath Hiatal Augmentation in Paraesophageal Hernia Repair

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Chicago
Study ID
NCT06551077
Status
Recruiting
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Conditions

  • Paraesophageal Hernia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • POSTERIOR RECTUS SHEATH HIATAL AUGMENTATION (PORSHA) — PROCEDURE
    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.

Study Details

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.

Key Dates

Start date
May 15, 2024
Status verified
Jan 2026
Primary completion
May 31, 2029
Completion
May 31, 2029

Study Design

Enrollment
100 participants (estimated)

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

Locations (1)

FacilityCityStateZIPSite coordinators
The University of ChicagoChicagoIllinois60637
Hira Khan
[email protected]
773-702-1220
Carlisa Dixon
[email protected]
7738344337
Yalini Vigneswaran, MD, MPH (PRINCIPAL_INVESTIGATOR)

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By research site
The University of Chicago· Chicago, IL

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