Posterior Rectus Sheath Hiatal Augmentation in Paraesophageal Hernia Repair

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Chicago

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • POSTERIOR RECTUS SHEATH HIATAL AUGMENTATION (PORSHA)

    Procedure/Surgery

    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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

Number or participants with Symptom Relief

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

Number of participants with use of anti-acid medications

Time frame
At 6 months, 2 year and 5 years' time points
3

Number of participants with dysphagia symptoms

Time frame
At 6 months, 2 year and 5 years' time points
4

Number of participants with abdominal wall deformities or symptoms

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

Other outcomes

Sponsors and contacts

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