Veritas Laparoscopic Paraesophageal Hiatal Hernia (PEH) Repair Pilot Trial

• ClinicalTrials.gov Identifier: NCT01195545
• Recruitment Status: Completed
• First Posted: September 6, 2010
• Results First Posted: July 10, 2018
• Last Update Posted: July 10, 2018
• Sponsor: University of Washington
• Collaborator: Synovis Surgical Innovations
• Information provided by (Responsible Party): Brant Oelschlager, University of Washington

Study Description

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: N/A
• 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

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Device: Veritas® Collagen Matrix; biological mesh in hernia repair

Outcome Measures

Primary Outcome Measures :

1. Recurrence Rate of Hiatal Hernia Rate Based on Upper Gastrointestinal (UGI) Series [ Time Frame: 6 months post procedure ]
   Number of subjects experiencing recurrence greater than 2cm as well as 5cm post surgery.

Secondary Outcome Measures :

1. Pre and Post-operative Symptoms [ Time Frame: Pre-surgery and 6 month follow up ]

   Heartburn frequency Pre and Post-operative was measured using the Paraesophagel Hernia Patient Questionnaire-Visual analog score (VAS). The VAS measures subjective characteristics that specify the respondents level of agreement to a statement. In this questionnaire, the patient indicated how frequent they had Heartburn. The Heartburn frequency measurement scale: 0=Never, 1=once/month,2=once/week,3=once/day,4=several/day. The lower the VAS score the better the outcome meaning less episodes of Heartburn.

   The Heartburn VAS score was measured pre-operative and post-operative. The comparison of Heartburn VAS score pre-operative and post-operative indicated that participants experienced Improvement and No Improvement.

2. Pre and Post-operative Symptoms [ Time Frame: Pre-surgery and 6 month follow up ]

   Regurgitation frequency Pre and Post-operative was measured using the Paraesophagel Hernia Patient Questionnaire-Visual analog score (VAS). The VAS measures subjective characteristics that specify the respondents level of agreement to a statement. In this questionnaire, the patient indicated how frequent they had Regurgitation. The Regurgitation frequency measurement scale: 0=Never, 1=once/month,2=once/week,3=once/day,4=several/day. The lower the VAS score the better the outcome meaning less episodes of Regurgitation.

   The Regurgitation VAS score was measured pre-operative and post-operative. The comparison of Regurgitation VAS score pre-operative and post-operative indicated that participants experienced Improvement and No Improvement.

3. Pre and Post-operative Symptoms [ Time Frame: Pre-surgery and 6 month follow up ]

   Dysphagia frequency Pre and Post-operative was measured using the Paraesophagel Hernia Patient Questionnaire-Visual analog score (VAS). The VAS measures subjective characteristics that specify the respondents level of agreement to a statement. In this questionnaire, the patient indicated how frequent they had Dysphagia. The Dysphagia frequency measurement scale: 0=Never, 1=once/month,2=once/week,3=once/day,4=several/day. The lower the VAS score the better the outcome meaning less episodes of Dysphagia.

   The Dysphagia VAS score was measured pre-operative and post-operative. The comparison of Dysphagia VAS score pre-operative and post-operative indicated that some participants experienced Improvement and others worsen.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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 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)

Contacts and Locations

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

• Responsible Party: Brant Oelschlager, Professor and Chief of General Surgery, Surgery, General Surgery Division, University of Washington
• ClinicalTrials.gov Identifier: NCT01195545
• Other Study ID Numbers: 38048
• First Posted: September 6, 2010
• Results First Posted: July 10, 2018
• Last Update Posted: July 10, 2018
• Last Verified: June 2018

Keywords provided by Brant Oelschlager, University of Washington:

Veritas® Collagen Matrix, Hiatal hernia

Additional relevant MeSH terms:

Hernia; Hernia, Hiatal; Pathological Conditions, Anatomical; Hernia, Diaphragmatic; Internal Hernia