Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06551077
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-08
Brief Title:
Posterior Rectus Sheath Hiatal Augmentation in Paraesophageal Hernia Repair
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Prospective Trial of Posterior Rectus Sheath Hiatal Augmentation PORSHA in Paraesophageal Hernia Repair
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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
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 patients 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 patients 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
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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None