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| Name | Class |
|---|---|
| Synovis Surgical Innovations | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Veritas® Collagen Matrix | Device | biological mesh in hernia repair |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
A. Subjects must have a documented symptomatic paraesophageal hernia that:
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)
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| Name | Affiliation | Role |
|---|---|---|
| Brant K. Oelschlager, M.D. | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington | Seattle | Washington | 98195 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 the repair. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 the repair. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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-op follow up | Posted | Count of Participants | Participants | 6 months post procedure |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 the repair. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brant Oelschlager, MD | University of Washington | 206-543-3518 | brant@uw.edu |
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| ID | Term |
|---|---|
| D006551 | Hernia, Hiatal |
| ID | Term |
|---|---|
| D006548 | Hernia, Diaphragmatic |
| D000082122 | Internal Hernia |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
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| Pre-surgery and 6 month follow up |
| 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-surgery and 6 month follow up |
| 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. | Pre-surgery and 6 month follow up |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Median | Full Range | kg/m^2 |
|
|
|
| Secondary | 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-surgery and at a median follow up 6 months month (range 3 - 10 months) | Posted | Count of Participants | Participants | Pre-surgery and 6 month follow up |
|
|
|
| Secondary | 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-surgery an at median follow up of 6 month (3-6 month) | Posted | Count of Participants | Participants | Pre-surgery and 6 month follow up |
|
|
|
| Secondary | 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. | Pre-surgery and a median of 6 month follow up (3-6months) | Posted | Count of Participants | Participants | Pre-surgery and 6 month follow up |
|
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| 0 |
| 16 |
| 0 |
| 16 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |