Clinical trial NCT03735862: Complications, Outcomes and Revisions Following Hiatal Hernia Repair With MIROMESH
Official title: Complications and 1-Year Outcomes Following Hiatal Hernia Repair With MIROMESH a Novel, Highly Vascular, Porcine Derived, Biologic Matrix
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hiatal Hernia With Gastroesophageal Reflux Disease
Gastroesophageal Reflux
GERD
Lead sponsor: Miromatrix Medical Inc.
Sponsor class: INDUSTRY
First posted: 2018-11-08
Enrollment: 85
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Had a hiatal hernia repair with MIROMESH greater than 6 months prior to study

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?

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Number of Subjects Who Required a Revision of the Index Surgery.
timeFrame: 6-18 months post index procedure
Secondary outcomes:
measure: Gastroesophageal Reflux Disease Health Related Quality of Life Score (GERD-HRQL)
timeFrame: 6-18 months post index procedure
measure: Medication Use
timeFrame: 6-18 months post index procedure
Other outcomes:
measure: Satisfaction With Procedure
timeFrame: 6-18 Months post index procedure
measure: Likelihood to Recommend
timeFrame: 6-18 Months post index procedure
Locations:
city: Lorton
country: United States
facility: Virginia Heartburn and Hernia Institute
state: Virginia
Study officials:
affiliation: Virginia Heartburn and Hernia Institute
name: George K Gillian, M.D.
role: PRINCIPAL_INVESTIGATOR
References: