Veritas Laparoscopic Paraesophageal Hiatal Hernia (PEH) Repair Pilot Trial
This trial has been completed.
|Treatment||veritas® collagen matrix|
|Sponsor||University of Washington|
|Collaborator||Synovis Surgical Innovations|
|Start date||May 2010|
|End date||December 2012|
|Trial size||20 participants|
|Trial identifier||NCT01195545, 38048-D|
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.
|Intervention model||single group assignment|
Recurrence rate of Hiatal Hernia rate based on UGI series
time frame: Pre-operative, procedure and 6-months
Pre and Post-operative symptoms and Quality of Life Assessments
time frame: pre-operative visit and at 6 months post-op
Male or female participants at least 18 years old.
Inclusion Criteria: A. Subjects must have a documented symptomatic paraesophageal hernia that: - 1. Is greater than 5 cm hiatal hernia on UGI series - 2. Has evidence that the stomach or other viscera is present in the hernia and does not spontaneously reduce from the mediastinum - 3. Has significant symptoms or signs of a paraesophageal hernia: heartburn, dysphagia, chest pain, shortness of breath, post-prandial abdominal pain, early satiety, odynophagia or chronic anemia B. Consenting adult ≥18 years ~ documentation of informed consent will be recorded in the research records C. Must be able to participate in follow-up evaluations (subjects must be fully cognitive) D. Has a telephone E. Free of cognitive or speech impairment Exclusion Criteria: A. Previous operation of the esophagus or stomach B. Associated gastrointestinal diseases that require extensive medical or surgical intervention that might interfere with quality of life assessment (e.g. Crohn's disease) C. Emergent operation for acute volvulus (twisting/rotation of the bowel leading to obstruction)
|Official title||Veritas Laparoscopic PEH Repair Pilot Trial|
|Principal investigator||Brant K. Oelschlager, M.D.|
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