Complications, Outcomes and Revisions Following Hiatal Hernia Repair With MIROMESH
|ClinicalTrials.gov Identifier: NCT03735862|
Recruitment Status : Completed
First Posted : November 8, 2018
Results First Posted : August 5, 2019
Last Update Posted : October 1, 2019
|Condition or disease||Intervention/treatment|
|Hiatal Hernia With Gastroesophageal Reflux Disease Gastroesophageal Reflux GERD||Biological: Hepatic derived surgical matrix|
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.
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
- Date of birth
- 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
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 :||Observational|
|Actual Enrollment :||85 participants|
|Official Title:||Complications and 1-Year Outcomes Following Hiatal Hernia Repair With MIROMESH a Novel, Highly Vascular, Porcine Derived, Biologic Matrix|
|Actual Study Start Date :||June 1, 2017|
|Actual Primary Completion Date :||June 1, 2018|
|Actual Study Completion Date :||October 1, 2018|
Patients who have undergone a hiatal hernia repair with MIROMESH.
Biological: Hepatic derived surgical matrix
Hiatal hernia repair with MIROMESH
Other Name: MIROMESH Biologic Matrix
- 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.
- 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.
- Medication Use [ Time Frame: 6-18 months post index procedure ]Use of PPIs in 3-months prior to follow-up interview
- Satisfaction With Procedure [ Time Frame: 6-18 Months post index procedure ]Patients reported their satisfaction with the procedure as "Dissatisfied", "Neutral", or Satisfied.
- 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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03735862
|United States, Virginia|
|Virginia Heartburn and Hernia Institute|
|Lorton, Virginia, United States, 22079|
|Principal Investigator:||George K Gillian, M.D.||Virginia Heartburn and Hernia Institute|