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Completed

NCT Number: NCT03735862

Complications, Outcomes and Revisions Following Hiatal Hernia Repair With MIROMESH

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

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Key information

Conditions

Hiatal Hernia With Gastroesophageal Reflux Disease Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders GERD Gastroesophageal Reflux Gastrointestinal Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Virginia Heartburn and Hernia Institute

Lorton, Virginia, 22079, United States

About this study

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?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • N/A

Treatment and study plan

Hepatic derived surgical matrix

Biological

Hiatal hernia repair with MIROMESH

Other names: MIROMESH Biologic Matrix

Primary outcomes

  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 outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Miromatrix Medical Inc.

Industry

Registry information

Official study title

Complications and 1-Year Outcomes Following Hiatal Hernia Repair With MIROMESH a Novel, Highly Vascular, Porcine Derived, Biologic Matrix

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 8, 2018
Registry last updated
Oct 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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