Complications, Outcomes and Revisions Following Hiatal Hernia Repair With MIROMESH

Miromatrix Medical

Status: Completed

Conditions: Hiatal Hernia With Gastroesophageal Reflux Disease; Gastroesophageal Reflux; GERD

Treatments: Biological: Hepatic derived surgical matrix

Study type: Observational

Funder types: Industry

Identifiers

NCT03735862

20174001

Details and patient eligibility

About

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

Full 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?

Enrollment: 85 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• N/A

Trial design

85 participants in 1 patient group

Observations Group

Description:

Patients who have undergone a hiatal hernia repair with MIROMESH.

Treatment:

Biological: Hepatic derived surgical matrix