NCT06551077 Posterior Rectus Sheath Hiatal Augmentation in Paraesophageal Hernia Repair
| NCT ID | NCT06551077 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Chicago |
| Condition | Paraesophageal Hernia |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-05-15 |
| Primary Completion | 2029-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2024-05-15 with a primary completion date of 2029-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Yalini Vigneswaran, MD, MPH
PRINCIPAL INVESTIGATOR
University of Chicago
Frequently Asked Questions
Who can join the NCT06551077 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Paraesophageal Hernia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06551077 currently recruiting?
Yes, NCT06551077 is actively recruiting participants. Contact the research team at yvigneswaran@bsd.uchicago.edu for enrollment information.
Where is the NCT06551077 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT06551077 clinical trial?
NCT06551077 is sponsored by University of Chicago. The principal investigator is Yalini Vigneswaran, MD, MPH at University of Chicago. The trial plans to enroll 100 participants.