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

Investigator will identify a consecutive cohort of patients who have undergone a hiatal hernia repair and are at least 6 months post index procedure.

Study Overview

• Status: Completed
• Conditions: Gastroesophageal Reflux; GERD; Hiatal Hernia With Gastroesophageal Reflux Disease
• Intervention / Treatment: Biological: Hepatic derived surgical matrix

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: Observational
• Enrollment (Actual): 85

Contacts and Locations

Study Locations

• United States
  • 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: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Had a hiatal hernia repair with MIROMESH greater than 6 months prior to study

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?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observations Group; Patients who have undergone a hiatal hernia repair with MIROMESH.	Biological: Hepatic derived surgical matrix; Hiatal hernia repair with MIROMESH; Other Names: MIROMESH Biologic Matrix

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.	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)	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	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	Patients reported their satisfaction with the procedure as "Dissatisfied", "Neutral", or Satisfied.	6-18 Months post index procedure
Likelihood to Recommend	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: Miromatrix Medical Inc.
• Investigators: Principal Investigator: George K Gillian, M.D., Virginia Heartburn and Hernia Institute

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2017
• Primary Completion (ACTUAL): June 1, 2018
• Study Completion (ACTUAL): October 1, 2018

Study Registration Dates

• First Submitted: November 7, 2018
• First Submitted That Met QC Criteria: November 7, 2018
• First Posted (ACTUAL): November 8, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 1, 2019
• Last Update Submitted That Met QC Criteria: September 17, 2019
• Last Verified: September 1, 2019

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)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No