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
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