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Posterior Rectus Sheath Hiatal Augmentation in Paraesophageal Hernia Repair
Prospective Trial of Posterior Rectus Sheath Hiatal Augmentation (PORSHA) in Paraesophageal Hernia Repair
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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.
About the study
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.
What is being tested
- POSTERIOR RECTUS SHEATH HIATAL AUGMENTATION (PORSHA) (procedure)
Sponsor: University of Chicago · Participants: 100 · Started: May 15, 2024
Contact the study team
- Yalini Vigneswaran · Phone: 773-702-6337
Official record on ClinicalTrials.gov — NCT06551077
Locations in the U.S.
| Illinois | The University of Chicago, Chicago |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.