Veritas Laparoscopic Paraesophageal Hiatal Hernia (PEH) Repair Pilot Trial

NCT01195545 | Completed Results

• 1 other identifier: 38048
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

Veritas® Collagen Matrix, Hiatal hernia

Outcome Measures

Primary Outcomes (1)

• Recurrence Rate of Hiatal Hernia Rate Based on Upper Gastrointestinal (UGI) Series

  Number of subjects experiencing recurrence greater than 2cm as well as 5cm post surgery.

  6 months post procedure

Secondary Outcomes (3)

• Pre and Post-operative Symptoms

  Pre-surgery and 6 month follow up

• Pre and Post-operative Symptoms

  Pre-surgery and 6 month follow up

• Pre and Post-operative Symptoms

  Pre-surgery and 6 month follow up

Study Arms (1)

Veritas Mesh in Hernia Repair

EXPERIMENTAL

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.

Device: Veritas® Collagen Matrix

Interventions

Veritas® Collagen Matrix DEVICE

biological mesh in hernia repair

Veritas Mesh in Hernia Repair

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A. Subjects must have a documented symptomatic paraesophageal hernia that:
• \. Is greater than 5 cm hiatal hernia on Upper Gastrointestinal (UGI) series
• \. Has evidence that the stomach or other viscera is present in the hernia and does not spontaneously reduce from the mediastinum
• \. 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Washington: lead
• Synovis Surgical Innovations: collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Hernia, Hiatal

Condition Hierarchy (Ancestors)

Hernia, Diaphragmatic; Internal Hernia; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Brant Oelschlager, MD
• Organization: University of Washington

brant@uw.edu

206-543-3518

Study Officials

• Brant K. Oelschlager, M.D.

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chief of General Surgery, Surgery, General Surgery Division

Study Record Dates

• First Submitted: September 2, 2010
• First Posted: September 6, 2010
• Study Start: May 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2013
• Last Updated: July 10, 2018
• Results First Posted: July 10, 2018

Record last verified: 2018-06

Locations

US (1)