Veritas Laparoscopic Paraesophageal Hiatal Hernia (PEH) Repair Pilot Trial

• Sponsor: University of Washington (Other)
• Overall Status: Completed
• CT.gov ID: NCT01195545
• Collaborator: Synovis Surgical Innovations (Industry)
• Enrollment: 20
• Location: 1
• Arm: 1
• Duration (Months): 43
• Patients Per Site Per Month: 0.5

Study Details

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	N/A

Study Design

• Study Type: Interventional
• 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 1, 2010
• Actual Primary Completion Date: Dec 1, 2012
• Actual Study Completion Date: Dec 1, 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 [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 [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 [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 [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

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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
• 1. Has evidence that the stomach or other viscera is present in the hernia and does not spontaneously reduce from the mediastinum
• 1. 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

1. Consenting adult ≥18 years ~ documentation of informed consent will be recorded in the research records

2. Must be able to participate in follow-up evaluations (subjects must be fully cognitive)

3. Has a telephone

4. Free of cognitive or speech impairment

Exclusion Criteria:

1. Previous operation of the esophagus or stomach

2. Associated gastrointestinal diseases that require extensive medical or surgical intervention that might interfere with quality of life assessment (e.g. Crohn's disease)

3. Emergent operation for acute volvulus (twisting/rotation of the bowel leading to obstruction)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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: Sep 6, 2010
• Last Update Posted: Jul 10, 2018
• Last Verified: Jun 1, 2018

• Keywords provided by Brant Oelschlager, Professor and Chief of General Surgery, Surgery, General Surgery Division, University of Washington: Veritas® Collagen Matrix, Hiatal hernia
• Additional relevant MeSH terms: Hernia; Hernia, Hiatal

Study Results

Participant Flow

Arm/Group Title	Veritas Mesh in Hernia Repair
Arm/Group Description	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 the repair.
Period Title: Overall Study
STARTED	20
COMPLETED	16
NOT COMPLETED	4

Baseline Characteristics

Arm/Group Title	Veritas Mesh in Hernia Repair
Arm/Group Description	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 the repair.
Overall Participants	20
Age, Customized (years) [Median (Full Range) ]
Age	66
Sex: Female, Male (Count of Participants)
Female	16 80%
Male	4 20%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
United States	20 100%
BMI (kg/m^2) [Median (Full Range) ]
Median (Full Range) [kg/m^2]	28.7

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

6 months post-op follow up

Arm/Group Title	Veritas Mesh in Hernia Repair
Arm/Group Description	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 the repair.
Measure Participants	16
Recurrence >2cm	6 30%
Recurrence >5cm	2 10%
No evidence of recurrence.	8 40%

2. Secondary Outcome

Title	Pre and Post-operative Symptoms
Description	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.
Time Frame	Pre-surgery and 6 month follow up

Outcome Measure Data

Analysis Population Description

Pre-surgery and at a median follow up 6 months month (range 3 - 10 months)

Arm/Group Title	Veritas Mesh in Hernia Repair
Arm/Group Description	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 the repair.
Measure Participants	16
With Improvement of Heartburn	15 75%
No Improvement of Heartburn	1 5%

3. Secondary Outcome

Title	Pre and Post-operative Symptoms
Description	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.
Time Frame	Pre-surgery and 6 month follow up

Outcome Measure Data

Analysis Population Description

Pre-surgery an at median follow up of 6 month (3-6 month)

Arm/Group Title	Veritas Mesh in Hernia Repair
Arm/Group Description	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 the repair.
Measure Participants	16
Improvement in regurgitation	11 55%
No improvement in regurgitation	5 25%

4. Secondary Outcome

Title	Pre and Post-operative Symptoms
Description	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.
Time Frame	Pre-surgery and 6 month follow up

Outcome Measure Data

Analysis Population Description

Pre-surgery and a median of 6 month follow up (3-6months)

Arm/Group Title	Veritas Mesh in Hernia Repair
Arm/Group Description	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 the repair.
Measure Participants	16
Dysphagia Improved	14 70%
Dysphagia worsen	2 10%

Adverse Events

Arm/Group Title	Experimental
Arm/Group Description	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 the repair.
All Cause Mortality
	Experimental
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Experimental
	Affected / at Risk (%)	# Events
Total	0/16 (0%)
Other (Not Including Serious) Adverse Events
	Experimental
	Affected / at Risk (%)	# Events
Total	0/16 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.