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Veritas Laparoscopic Paraesophageal Hiatal Hernia (PEH) Repair Pilot Trial

Primary Purpose

Hiatal Hernia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Veritas® Collagen Matrix
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hiatal Hernia focused on measuring Veritas® Collagen Matrix, Hiatal hernia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Washington

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Veritas Mesh in Hernia Repair

Arm 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 repair.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Pre and Post-operative Symptoms
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.
Pre and Post-operative Symptoms
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.
Pre and Post-operative Symptoms
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.

Full Information

First Posted
September 2, 2010
Last Updated
June 8, 2018
Sponsor
University of Washington
Collaborators
Synovis Surgical Innovations
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1. Study Identification

Unique Protocol Identification Number
NCT01195545
Brief Title
Veritas Laparoscopic Paraesophageal Hiatal Hernia (PEH) Repair Pilot Trial
Official Title
Veritas Laparoscopic PEH Repair Pilot Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
Synovis Surgical Innovations

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hiatal Hernia
Keywords
Veritas® Collagen Matrix, Hiatal hernia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Veritas Mesh in Hernia Repair
Arm Type
Experimental
Arm 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 repair.
Intervention Type
Device
Intervention Name(s)
Veritas® Collagen Matrix
Intervention Description
biological mesh in hernia repair
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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
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
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brant K. Oelschlager, M.D.
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

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Veritas Laparoscopic Paraesophageal Hiatal Hernia (PEH) Repair Pilot Trial

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