Complications, Outcomes and Revisions Following Hiatal Hernia Repair With MIROMESH

Gastroesophageal Reflux Clinical Trial

Official title: Complications and 1-Year Outcomes Following Hiatal Hernia Repair With MIROMESH a Novel, Highly Vascular, Porcine Derived, Biologic Matrix

Status Completed

Clinical Trial Summary

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

Clinical Trial 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? ;

Related Conditions & MeSH terms

• Esophagitis, Peptic
• Gastroesophageal Reflux
• GERD
• Hernia
• Hernia, Hiatal
• Hiatal Hernia With Gastroesophageal Reflux Disease

• NCT number: NCT03735862
• Study type: Observational
• Source: Miromatrix Medical Inc.
• Status: Completed
• Start date: June 1, 2017
• Completion date: October 1, 2018