Complications, Outcomes and Revisions Following Hiatal Hernia Repair With MIROMESH
NCT ID: NCT03735862
Last Updated: 2019-10-01
Study Results
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View full resultsBasic Information
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COMPLETED
85 participants
OBSERVATIONAL
2017-06-01
2018-10-01
Brief Summary
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Detailed Description
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Study Population: A consecutive cohort of patients who have undergone a hiatal hernia repair with MIROMESH.
Primary Objective: Characterize the procedural and early post-operative safety profile of MIROMESH when used as reinforcement in hiatal hernia repair.
Secondary Objectives
A retrospective chart review will identify the appropriate cohort with a prospective follow-up survey to acquire safety and outcome information.
A retrospective chart review of appropriate subjects.
Data to be acquired will be:
Preoperative - Chart Review
* Gender
* Date of birth
* Weight
* Body Mass Index
* Specific diagnosis
* DeMeester Score
* 24 hour pH test (% acid exposure in 24 hours)
* Gastroesophageal Reflux Disease Health Related Quality of Life (GERD-HRQL) Score Peri-operative Preoperative - Chart Review
* Date of surgery
* Number of stitches used to close wound
* Paraesophageal hernia type
* Mesh shape
* Mesh size used
* Attachment technique
* Length of stay
* Complications
Post-Operative (With-in 1 month of surgery) Preoperative - Chart Review
* Complications (Mesh related)
* Complications (procedure related)
* Prolonged dysphagia (Y/N)
* Stenosis (Y/N)
* Dilations (Y/N)
* Esophagogastroduodenoscopy or Upper gastrointestinal series documented hernia recurrence
* GERD-HRQL Score
Prospective institutional review board approved Follow-Up Telephone Interview
* Have you had a revision surgery?
* GERD-HRQL Score
* How satisfied are you with the procedure?
* Have you used proton pump inhibitors in the last 3 months
* How likely are you to recommend this procedure to a loved one?
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Observations Group
Patients who have undergone a hiatal hernia repair with MIROMESH.
Hepatic derived surgical matrix
Hiatal hernia repair with MIROMESH
Interventions
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Hepatic derived surgical matrix
Hiatal hernia repair with MIROMESH
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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Miromatrix Medical Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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George K Gillian, M.D.
Role: PRINCIPAL_INVESTIGATOR
Virginia Heartburn and Hernia Institute
Locations
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Virginia Heartburn and Hernia Institute
Lorton, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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20174001
Identifier Type: -
Identifier Source: org_study_id
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