Complications, Outcomes and Revisions Following Hiatal Hernia Repair With MIROMESH

Completed

Conditions: Hiatal Hernia With Gastroesophageal Reflux Disease
Gastroesophageal Reflux
GERD

Interventions: Biological: Hepatic derived surgical matrix

Registration Number: NCT03735862

Lead Sponsor: Miromatrix Medical Inc.

Brief 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.

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?

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 85

Inclusion Criteria

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

Exclusion Criteria

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observations Group	Hepatic derived surgical matrix	Patients who have undergone a hiatal hernia repair with MIROMESH.

Primary Outcome Measures

Name	Time	Method
Number of Subjects Who Required a Revision of the Index Surgery.	6-18 months post index procedure	Patient self-report if they had a revision or other laparoscopic surgery following index procedure.

Secondary Outcome Measures

Name	Time	Method
Medication Use	6-18 months post index procedure	Use of PPIs in 3-months prior to follow-up interview
Gastroesophageal Reflux Disease Health Related Quality of Life Score (GERD-HRQL)	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.