Veritas Laparoscopic Paraesophageal Hiatal Hernia (PEH) Repair Pilot Trial

NCT ID: NCT01195545

Last Updated: 2018-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2013-12-31

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.

Conditions

Hiatal Hernia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Veritas Mesh in Hernia Repair

Subjects undergoing laparoscopic paraesophageal hiatal hernia repair using a bovine pericardium mesh (BP) (Veritas® Collagen Matrix, Synovis ®, St. Paul MN) as a reinforcing material during repair.

Group Type: EXPERIMENTAL

Veritas® Collagen Matrix

Intervention Type: DEVICE

biological mesh in hernia repair

Interventions

Veritas® Collagen Matrix

biological mesh in hernia repair

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

A. Subjects must have a documented symptomatic paraesophageal hernia that:

• 1. Is greater than 5 cm hiatal hernia on Upper Gastrointestinal (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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Synovis Surgical Innovations

INDUSTRY

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Brant Oelschlager

Professor and Chief of General Surgery, Surgery, General Surgery Division

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brant K. Oelschlager, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

University of Washington

Seattle, Washington, United States

Countries

United States

Other Identifiers

38048

Identifier Type: -

Identifier Source: org_study_id