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Complications, Outcomes and Revisions Following Hiatal Hernia Repair With MIROMESH

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03735862
Recruitment Status : Completed
First Posted : November 8, 2018
Results First Posted : August 5, 2019
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Hiatal Hernia With Gastroesophageal Reflux Disease Gastroesophageal Reflux GERD Biological: Hepatic derived surgical matrix

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?

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Study Type : Observational
Actual Enrollment : 85 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Complications and 1-Year Outcomes Following Hiatal Hernia Repair With MIROMESH a Novel, Highly Vascular, Porcine Derived, Biologic Matrix
Actual Study Start Date : June 1, 2017
Actual Primary Completion Date : June 1, 2018
Actual Study Completion Date : October 1, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Observations Group
Patients who have undergone a hiatal hernia repair with MIROMESH.
Biological: Hepatic derived surgical matrix
Hiatal hernia repair with MIROMESH
Other Name: MIROMESH Biologic Matrix




Primary Outcome Measures :
  1. Number of Subjects Who Required a Revision of the Index Surgery. [ Time Frame: 6-18 months post index procedure ]
    Patient self-report if they had a revision or other laparoscopic surgery following index procedure.


Secondary Outcome Measures :
  1. Gastroesophageal Reflux Disease Health Related Quality of Life Score (GERD-HRQL) [ Time Frame: 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.

  2. Medication Use [ Time Frame: 6-18 months post index procedure ]
    Use of PPIs in 3-months prior to follow-up interview


Other Outcome Measures:
  1. Satisfaction With Procedure [ Time Frame: 6-18 Months post index procedure ]
    Patients reported their satisfaction with the procedure as "Dissatisfied", "Neutral", or Satisfied.

  2. Likelihood to Recommend [ Time Frame: 6-18 Months post index procedure ]
    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).



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Had a hiatal hernia repair with MIROMESH greater than 6 months prior to study
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • N/A

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03735862


Locations
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United States, Virginia
Virginia Heartburn and Hernia Institute
Lorton, Virginia, United States, 22079
Sponsors and Collaborators
Miromatrix Medical Inc.
Investigators
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Principal Investigator: George K Gillian, M.D. Virginia Heartburn and Hernia Institute
  Study Documents (Full-Text)

Documents provided by Miromatrix Medical Inc.:

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Responsible Party: Miromatrix Medical Inc.
ClinicalTrials.gov Identifier: NCT03735862     History of Changes
Other Study ID Numbers: 20174001
First Posted: November 8, 2018    Key Record Dates
Results First Posted: August 5, 2019
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophagitis, Peptic
Hernia
Hernia, Hiatal
Pathological Conditions, Anatomical
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Esophagitis
Gastroenteritis
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases
Hernia, Diaphragmatic