Paraesophageal HerniaNCT06551077
Posterior Rectus Sheath Hiatal Augmentation in Paraesophageal Hernia Repair
An observational study of Paraesophageal Hernia, run by University of Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paraesophageal Hernia
- What is being tested?
- POSTERIOR RECTUS SHEATH HIATAL AUGMENTATION (PORSHA)
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2024to May 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- All patients undergoing PoRSHA. PoRSHA will be offered to all patients with PEH defects measuring greater than 4 cm.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hira Khan contact
United States1 site, 1 recruiting
- Recruiting
The University of Chicago
Chicago, Illinois, 60637
Hira Khan, 773-702-1220, hira.khan@bsd.uchicago.edu
Carlisa Dixon, 7738344337, cdixon520@bsd.uchicago.edu
About this study
Official title: Prospective Trial of Posterior Rectus Sheath Hiatal Augmentation (PORSHA) in Paraesophageal Hernia Repair
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.
- Conditions
- Paraesophageal Hernia
- Being tested
- POSTERIOR RECTUS SHEATH HIATAL AUGMENTATION (PORSHA)
- Medical subject headings
- Hernia, Hiatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POSTERIOR RECTUS SHEATH HIATAL AUGMENTATION (PORSHA)Procedure or 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with recurrence of hernia as seen radiographically at routine esophagram
Measured: At 6 months, 2 year and 5 years' time points
Secondary outcomes (4)
Number or participants with Symptom Relief
Measured: At 6 months, 2 year and 5 years' time points
Number of participants with use of anti-acid medications
Measured: At 6 months, 2 year and 5 years' time points
Number of participants with dysphagia symptoms
Measured: At 6 months, 2 year and 5 years' time points
Number of participants with abdominal wall deformities or symptoms
Measured: At 6 months, 2 year and 5 years' time points
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start15 May 2024
- Primary completionMay 2029 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paraesophageal HerniaStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yalini Vigneswaran, MD, MPH, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06551077
- Sponsor's protocol ID
- IRB24-0322
- Status last verified
- Jan 2026
- First submitted
- 8 Aug 2024
- Last updated
- 2 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Trial of Posterior Rectus Sheath Hiatal Augmentation (PORSHA) in Paraesophageal Hernia Repair
- ClinicalTrials.gov ID
- NCT06551077
- Acronym / sponsor ID
- IRB24-0322
- Conditions
- Paraesophageal Hernia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 15 May 2024 (actual)
- Primary completion
- May 2029 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 13 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All patients undergoing PoRSHA. PoRSHA will be offered to all patients with PEH defects measuring greater than 4 cm.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| POSTERIOR 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. | Procedure or surgery | – |
Primary outcome
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
4 secondary outcomes
Number or participants with Symptom Relief
Time frame: At 6 months, 2 year and 5 years' time points
Number of participants with use of anti-acid medications
Time frame: At 6 months, 2 year and 5 years' time points
Number of participants with dysphagia symptoms
Time frame: At 6 months, 2 year and 5 years' time points
Number of participants with abdominal wall deformities or symptoms
Time frame: At 6 months, 2 year and 5 years' time points
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hira Khan contact
Yalini Vigneswaran, MD, MPH principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Paraesophageal Hernia, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yalini Vigneswaran (773-702-6337, yvigneswaran@bsd.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.