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RecruitingNCT06551077Updated Feb 2, 2026

Posterior Rectus Sheath Hiatal Augmentation in Paraesophageal Hernia Repair

An observational study in Paraesophageal Hernia, sponsored by University of Chicago. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-02.

Sponsored by University of Chicago · Observational

From the registry’s dates

  • Started May 2024; still recruiting 2 years 5 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
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Study 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.

Read the detailed description

One of the most challenging problems facing foregut surgeons is the large and complex paraesophageal hernia (PEH) repair in the older patient. Patients often present for surgery after decades of chronic reflux disease and a known hiatal hernia that has finally progressed to a complete intrathoracic stomach with symptoms concerning for a gastric volvulus. Surgery in such patients involves extensive mediastinal dissection to reduce the large hernia sac, repositioning of the gastroesophageal junction into the abdomen and then repair of a significantly attenuated defect in older patients with attenuated diaphragmatic muscle integrity. Challenges with PEH repair are multifactorial and include primary closure of weakened crural muscle in a large attenuated diaphragmatic defect; the absence of a substantial fascial layer to use to close the defect; and the avoidance of permanent mesh due to the risk of shrinkage, dysphagia and esophageal erosion. While a tension free repair is the goal, the use of relaxing incisions, fixation to posterior structures, and other such modifications have not proven to be universally beneficial.

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.

While initial use of this technique is promising, the investigator believes that long-term and large patient population is necessary to better evaluate the outcomes. The use of the IDEAL framework (Idea, Development, Exploration, Assessment and Long-term follow-up) framework for surgical innovation, to determine its safe development and overall evaluation as a surgical innovation. Using this framework the investigators will evaluate the long-term outcomes in a large patient population.

02

Conditions studied

  • Paraesophageal Hernia

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03

In context

Hernia, Hiatal

87 studies on the registry are indexed under Hernia, Hiatal; 27 are open to participants now.

This study's planned enrollment of 100 is below the median of 151 across 29 observational studies indexed under Hernia, Hiatal.

Browse Hernia, Hiatal studies →

Lead sponsor

University of Chicago is the lead sponsor of 924 studies on the registry; 185 are open to participants now.

Of its 103 completed or terminated interventional studies of FDA-regulated products, 72 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Interventions

  • ProcedurePOSTERIOR RECTUS SHEATH HIATAL AUGMENTATION (PORSHA)

    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.

06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06551077
Responsible party
Sponsor
First posted
Aug 13, 2024
Start date
May 15, 2024
Primary completion
May 2029 (estimated)
Completion
May 2029 (estimated)
Last update
Feb 2, 2026

Study contacts

Yalini Vigneswaran
Contact
yvigneswaran@bsd.uchicago.edu
773-702-6337
Yalini Vigneswaran, MD, MPH
principal investigator · University of Chicago

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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