Veritas Laparoscopic Paraesophageal Hiatal Hernia (PEH) Repair Pilot Trial

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by University of Washington.
Recruitment status was  Active, not recruiting
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

September 2, 2010
August 5, 2011
May 2010
December 2012   (final data collection date for primary outcome measure)
Recurrence rate of Hiatal Hernia rate based on UGI series [ Time Frame: Pre-operative, procedure and 6-months ] [ Designated as safety issue: No ]
Recurrence rate of Hiatal Hernia rate based on UGI series
Complete list of historical versions of study NCT01195545 on ClinicalTrials.gov Archive Site
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"
Same as current
Not Provided
Not Provided
 
Veritas Laparoscopic Paraesophageal Hiatal Hernia (PEH) Repair Pilot Trial
Veritas Laparoscopic PEH Repair Pilot Trial

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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hiatal Hernia
Device: Veritas® Collagen Matrix
biological mesh in hernia repair
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
20
December 2012
December 2012   (final data collection date for primary outcome measure)

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)

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01195545
38048-D
No
Brant Oelschlager, MD, University of Washington
University of Washington
Synovis Surgical Innovations
Principal Investigator: Brant K. Oelschlager, M.D. University of Washington
University of Washington
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP