Clinical Trials Logo

Clinical Trial Summary

This is an investigator initiated pilot study to observe the short-term outcomes (a follow-up period of up to six months) of patients who undergo a laparoscopic paraesophageal Hiatal hernia (PEH) repair using the Veritas® Collagen Matrix brand biological mesh. This is a preliminary study at the University of Washington.

A PEH occurs when the stomach protrudes through the diaphragm next to the esophagus. The chance of recurrence of a Hiatal hernia after laparoscopic PEH repair is between 20-40% within 6 months.During laparoscopic PEH repair, a mesh-type product is used as a scaffold. The mesh serves as a reinforcing material during the surgical repair. It is cut to the appropriate size needed for the hernia and sutured to the surrounding diaphragmatic tissue. There are many different types of meshes available on the market, and vary in the degree of manageability, strength, and adherence.

Although surgical meshes work on the same principal, the variance between materials may affect patient outcomes. There is evidence that a biologic mesh, specifically one derived from Small Intestinal Submucosa (SIS), decreases the short-term (6-month) recurrence rates compared to a synthetic mesh or another type of biologic mesh. A biologic mesh, serving as a scaffold, will be replaced by the patient's own tissue after about 6 months. Theoretically, this would prevent the possible complications associated with synthetic mesh including mesh erosion into the esophagus or stricture of the esophagus.

There are some case series showing similar short-term results between the different biologic meshes, but there is no direct comparative data.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT01195545
Study type Interventional
Source University of Washington
Contact
Status Completed
Phase N/A
Start date May 2010
Completion date December 2013

See also
  Status Clinical Trial Phase
Recruiting NCT04450628 - Esophagogastric Junction Distensibility During Hiatal Hernia Repair N/A
Active, not recruiting NCT06170060 - Treatment of Reflux With Sleeve Gastrectomy N/A
Recruiting NCT02242526 - Biologic Versus Synthetic Mesh for Treatment of Paraesophageal Hernia Phase 4
Active, not recruiting NCT00786084 - Study of Paraesophageal Hernia Repair With Small Intestine Submucosa N/A
Completed NCT00507377 - Foreshortened Esophagus and Its Surgical Therapy
Completed NCT05069493 - Long-term Follow-up After Hiatal Hernia Repair by Tension-free Mesh Closure or Simple Suturing
Completed NCT04716166 - Incentive Spirometry and Upper Abdominal Laparoscopic Surgery N/A
Recruiting NCT05953428 - Reducing Postoperative Opioids in Patients Undergoing Laparoscopic Hiatal Hernia N/A
Completed NCT01776827 - Long-term Outcome of Laparoscopic Hiatal Hernia Repair With or Without Alloderm Mesh at a University Hospital
Active, not recruiting NCT02923362 - Registry of Outcomes From AntiReflux Surgery
Completed NCT01118585 - Transoral Incisionless Fundoplication (TIF) Registry Study for Treatment of Gastroesophageal Reflux Disease (GERD) N/A
Recruiting NCT06432088 - Safety and Feasibility of Liver Retraction With the Levita Magnetic Surgical System: Extended Magnetic Grasper Device N/A
Recruiting NCT04936711 - Pain Relief After Hiatal Hernia Repair Surgery Phase 4
Not yet recruiting NCT04591860 - A Prospective Randomised Multi - Center Trial on the Repair of Large Hiatal Hernias: Absorbable Mesh vs. Pledgeted Sutures vs. Sutures Only N/A
Completed NCT01678157 - Use of Strattice Mesh in Paraesophageal Hernia Surgery
Completed NCT04282720 - SurgiMend Mesh at the Hiatus N/A
Not yet recruiting NCT06444347 - Impact of Biosynthetic Mesh on Paraesophageal Hernia Repair N/A
Recruiting NCT00260585 - Esophageal Cancer Risk Registry
Active, not recruiting NCT02328248 - Usage of Biological Patch Versus Plastic in the Laparoscopic Repair of Hiatal Hernias Phase 2/Phase 3
Recruiting NCT03776669 - Laparoscopic Sleeve Gastrectomy With or Without Hiatal Hernia Repair in Morbidly Obese Patients N/A