Posterior Rectus Sheath Hiatal Augmentation in Paraesophageal Hernia Repair

NCT06551077 | Recruiting

• 1 other identifier: IRB24-0322
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Number of participants with recurrence of hernia as seen radiographically at routine esophagram

  At 6 months, 2 year and 5 years' time points

Secondary Outcomes (4)

• Number or participants with Symptom Relief

  At 6 months, 2 year and 5 years' time points

• Number of participants with use of anti-acid medications

  At 6 months, 2 year and 5 years' time points

• Number of participants with dysphagia symptoms

  At 6 months, 2 year and 5 years' time points

• Number of participants with abdominal wall deformities or symptoms

  At 6 months, 2 year and 5 years' time points

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients who underwent PoRSHA at UCMC. We estimate 80-100 patients per year. This study is for all racial and ethnic origins.

You may qualify if:

• All patients undergoing PoRSHA. PoRSHA will be offered to all patients with PEH defects measuring greater than 4 cm.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

The University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

MeSH Terms

Conditions

Hernia, Hiatal

Condition Hierarchy (Ancestors)

Hernia, Diaphragmatic; Internal Hernia; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Yalini Vigneswaran, MD, MPH

  University of Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yalini Vigneswaran

CONTACT

773-702-6337; yvigneswaran@bsd.uchicago.edu

Hira Khan

CONTACT

hira.khan@bsd.uchicago.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: August 13, 2024
• Study Start: May 15, 2024
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2029
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)