- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03735862
Complications, Outcomes and Revisions Following Hiatal Hernia Repair With MIROMESH
Complications and 1-Year Outcomes Following Hiatal Hernia Repair With MIROMESH a Novel, Highly Vascular, Porcine Derived, Biologic Matrix
Study Overview
Status
Intervention / Treatment
Detailed Description
Planned Sample Size: At minimum of 70 consecutive subjects at least 6-months post-index procedure
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?
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Virginia
-
Lorton, Virginia, United States, 22079
- Virginia Heartburn and Hernia Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Had a hiatal hernia repair with MIROMESH greater than 6 months prior to study
Exclusion Criteria:
- N/A
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Observations Group
Patients who have undergone a hiatal hernia repair with MIROMESH.
|
Hiatal hernia repair with MIROMESH
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Subjects Who Required a Revision of the Index Surgery.
Time Frame: 6-18 months post index procedure
|
Patient self-report if they had a revision or other laparoscopic surgery following index procedure.
|
6-18 months post index procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gastroesophageal Reflux Disease Health Related Quality of Life Score (GERD-HRQL)
Time Frame: 6-18 months post index procedure
|
The GERD-HRQL score assess the severity of GERD symptomatic and impact on the subjects quality of life.
The score is comprised of 10 questions whose answers are summed for the final score.
THe score can range from 0 to 50, with 50 being the worst and 0 meaning no impact.
|
6-18 months post index procedure
|
Medication Use
Time Frame: 6-18 months post index procedure
|
Use of PPIs in 3-months prior to follow-up interview
|
6-18 months post index procedure
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Satisfaction With Procedure
Time Frame: 6-18 Months post index procedure
|
Patients reported their satisfaction with the procedure as "Dissatisfied", "Neutral", or Satisfied.
|
6-18 Months post index procedure
|
Likelihood to Recommend
Time Frame: 6-18 Months post index procedure
|
Patients were asked to report how likely they would be to recommend this procedure to a friend or loved one with the same condition.
Report was based on a scale of 1 (not at all likely) to 10 (very likely).
|
6-18 Months post index procedure
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: George K Gillian, M.D., Virginia Heartburn and Hernia Institute
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Gastrointestinal Diseases
- Stomach Diseases
- Gastroenteritis
- Intestinal Diseases
- Pathological Conditions, Anatomical
- Esophageal Motility Disorders
- Deglutition Disorders
- Esophageal Diseases
- Esophagitis
- Peptic Ulcer
- Duodenal Diseases
- Hernia, Diaphragmatic
- Internal Hernia
- Hernia
- Gastroesophageal Reflux
- Esophagitis, Peptic
- Hernia, Hiatal
Other Study ID Numbers
- 20174001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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