ACELL Mesh for Paraesophageal Hernia Repair

March 26, 2019 updated by: University of South Florida

Comparison of Symptomatic and Radiographic Outcomes of Paraesophageal Hernia Repair With and Without MatriStem Surgical Matrix

This is a prospective, case-matched, systematic follow up of up to 70 pre-existing patients whom underwent paraesophageal hernia repair between June 1, 2012 and September 30, 2016. Patients whom are willing to participate in the study will be asked to return for a one time follow up visit to reassess for hiatal hernia recurrence both symptomatically and radiologically to compare the efficacy of the use of MatriStem Surgical Matrix (ACell) mesh to other biologic meshes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The participating "MatriStem" patients (N=35) will be matched to "control" patients who were treated surgically by Dr. Vic Velanovich or Dr. Michael Albrink for paraesophageal hernia with a biological mesh other than MatriStem Surgical Matrix (N=35) during the study timeframe at Tampa General Hospital. Patients will be matched by age (+ 5 years), gender, and operative approach (laparoscopic, laparotomy, or thoracic approach).

Study participation will require only one visit. Once the patient signs the consent form, operative details and the postoperative course will be reviewed retrospectively.

Visit 1 (≥ 12 months post-PEHR)

  1. Review the study with the subject and/or subject's legal representative, and obtain written informed consent and HIPAA authorization.
  2. Assign the subject a unique screening/enrollment number (assigned sequentially starting from 001).
  3. Pregnancy test if subject is of childbearing potential
  4. Confirm subject eligibility.
  5. Record demographics data, which includes date of birth, race, ethnicity, and gender.
  6. Record current clinical symptoms in relation to the HH.
  7. Record medications, including over-the-counter and herbal medications, taken postoperatively in relation to the HH.
  8. Record medical history with respect to the paraesophageal hernia prior to the surgical repair. If available, the following information will be recorded: hernia type, hernia size, organo-axial, or meso-axial rotation, and operative approach (laparoscopic, laparotomy, or thoracic approach).
  9. Record medical history with respect to the paraesophageal hernia after the surgical repair (size of mesh implant, length of surgery [calculated as the time from incision to wound closure], postoperative complications to include need for reoperation, mesh migration, reherniation, etc [from date of hospital discharge to study visit], and symptom frequency).
  10. Perform esophagogram at TGH.
  11. Administer GERD-HRQL symptom severity questionnaire.
  12. Administer SF-36 generic quality of life instrument.

Study Type

Observational

Enrollment (Actual)

65

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33606
        • Tampa General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients that had a PEHR performed with a biological mesh between June 1, 2012 and September 30, 2016 at Tampa General Hospital

Description

Inclusion Criteria:

  • Age 18 years and older
  • Underwent primary or re-do PEHR with biological mesh by Dr. Vic Velanovich or Dr. Michael Albrink between June 1, 2012 and September 30, 2016
  • Written informed consent obtained from subject prior to esophagogram procedure and ability for subject to comply with the requirements of the study

Exclusion Criteria:

  • Age < 18 years of age
  • Underwent PEHR by a surgeon other than Dr. Vic Velanovich or Dr. Michael Albrink
  • Underwent PEHR outside of the timeframe of June 1, 2012 and September 30, 2016
  • Subject is involved in ongoing medical litigation, confirmed via subject report
  • Subject is incarcerated, confirmed via subject report
  • Pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Matristem
Hernia repair with MatriStem Surgical Matrix
Device: Matristem
Paraesophageal hernia repair with MatriStem Surgical Matrix
Control
Other biological mesh
Device: Control
Paraesophageal hernia repair with other biologic mesh

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of hernia recurrence
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean vertical height of hiatal hernia
Time Frame: 12 months
For patients with hiatal hernia recurrence
12 months
Mean cross-sectional area of hiatal hernia
Time Frame: 12 months
For patients with hiatal hernia recurrence
12 months
Rate of postoperative complications
Time Frame: 12 months
12 months
Mean GERD-Health Related QOL score
Time Frame: 12 months
12 months
Mean SF-36 QOL score
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of South Florida

Collaborators

Integra LifeSciences Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2016

Primary Completion (Actual)

April 1, 2018

Study Completion (Actual)

January 28, 2019

Study Registration Dates

First Submitted

February 16, 2017

First Submitted That Met QC Criteria

February 16, 2017

First Posted (Actual)

February 23, 2017

Study Record Updates

Last Update Posted (Actual)

March 28, 2019

Last Update Submitted That Met QC Criteria

March 26, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACELL01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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