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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03735862
• Other study ID #: 20174001
• Status: Completed
• Start date: June 1, 2017
• Est. completion date: October 1, 2018

Study information

• Verified date: September 2019
• Source: Miromatrix Medical Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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 information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: October 1, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• N/A

Related Conditions & MeSH terms

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

Intervention

Biological:
• Hepatic derived surgical matrix
Hiatal hernia repair with MIROMESH

Locations

Country	Name	City	State
United States	Virginia Heartburn and Hernia Institute	Lorton	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Miromatrix Medical Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Satisfaction With Procedure	Patients reported their satisfaction with the procedure as "Dissatisfied", "Neutral", or Satisfied.	6-18 Months post index procedure
Other	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
Primary	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	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
Secondary	Medication Use	Use of PPIs in 3-months prior to follow-up interview	6-18 months post index procedure