Veritas Laparoscopic Paraesophageal Hiatal Hernia (PEH) Repair Pilot Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01195545
Recruitment Status : Completed
First Posted : September 6, 2010
Last Update Posted : November 10, 2016
Synovis Surgical Innovations
Information provided by (Responsible Party):
Brant Oelschlager, University of Washington

Brief 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.

Condition or disease Intervention/treatment Phase
Hiatal Hernia Device: Veritas® Collagen Matrix Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Veritas Laparoscopic PEH Repair Pilot Trial
Study Start Date : May 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Collagen
U.S. FDA Resources

Intervention Details:
    Device: Veritas® Collagen Matrix
    biological mesh in hernia repair

Primary Outcome Measures :
  1. Recurrence rate of Hiatal Hernia rate based on UGI series [ Time Frame: Pre-operative, procedure and 6-months ]

Secondary Outcome Measures :
  1. Pre and Post-operative symptoms and Quality of Life Assessments [ Time Frame: pre-operative visit and at 6 months post-op ]
    SF-36v2, "Your health and well being"

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01195545

United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
Synovis Surgical Innovations
Principal Investigator: Brant K. Oelschlager, M.D. University of Washington

Responsible Party: Brant Oelschlager, Professor and Chief of General Surgery, Surgery, General Surgery Division, University of Washington Identifier: NCT01195545     History of Changes
Other Study ID Numbers: 38048-D
First Posted: September 6, 2010    Key Record Dates
Last Update Posted: November 10, 2016
Last Verified: November 2016

Keywords provided by Brant Oelschlager, University of Washington:
Veritas® Collagen Matrix, Hiatal hernia

Additional relevant MeSH terms:
Hernia, Hiatal
Pathological Conditions, Anatomical
Hernia, Diaphragmatic