Text Size

Veritas Laparoscopic Paraesophageal Hiatal Hernia (PEH) Repair Pilot Trial

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Synovis Surgical Innovations
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT01195545
First received: September 2, 2010
Last updated: August 5, 2011
Last verified: August 2011
History of Changes
  Purpose

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 Intervention
Hiatal Hernia
 Device: Veritas® Collagen Matrix

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Veritas Laparoscopic PEH Repair Pilot Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Recurrence rate of Hiatal Hernia rate based on UGI series [ Time Frame: Pre-operative, procedure and 6-months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pre and Post-operative symptoms and Quality of Life Assessments [ Time Frame: pre-operative visit and at 6 months post-op ] [ Designated as safety issue: No ]
    SF-36v2, "Your health and well being"


Estimated Enrollment: 20
Study Start Date: May 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Veritas® Collagen Matrix
    biological mesh in hernia repair
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01195545

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

No publications provided

Responsible Party: Brant Oelschlager, MD, University of Washington
ClinicalTrials.gov Identifier: NCT01195545     History of Changes
Other Study ID Numbers: 38048-D
Study First Received: September 2, 2010
Last Updated: August 5, 2011
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on June 17, 2013