NCT03058731

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 2, 2016

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

February 16, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2019

Completed
Last Updated

March 28, 2019

Status Verified

March 1, 2019

Enrollment Period

2.2 years

First QC Date

February 16, 2017

Last Update Submit

March 26, 2019

Conditions

Paraesophageal Hernia

Outcome Measures

Primary Outcomes (1)

  • Rate of hernia recurrence

    12 months

Secondary Outcomes (5)

  • Mean vertical height of hiatal hernia

    12 months

  • Mean cross-sectional area of hiatal hernia

    12 months

  • Rate of postoperative complications

    12 months

  • Mean GERD-Health Related QOL score

    12 months

  • Mean SF-36 QOL score

    12 months

Study Arms (2)

Matristem

Hernia repair with MatriStem Surgical Matrix

Device: Matristem

Control

Other biological mesh

Device: Control

Interventions

MatristemDEVICE

Paraesophageal hernia repair with MatriStem Surgical Matrix

Matristem
ControlDEVICE

Paraesophageal hernia repair with other biologic mesh

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Related Publications (4)

  • Oelschlager BK, Pellegrini CA, Hunter JG, Brunt ML, Soper NJ, Sheppard BC, Polissar NL, Neradilek MB, Mitsumori LM, Rohrmann CA, Swanstrom LL. Biologic prosthesis to prevent recurrence after laparoscopic paraesophageal hernia repair: long-term follow-up from a multicenter, prospective, randomized trial. J Am Coll Surg. 2011 Oct;213(4):461-8. doi: 10.1016/j.jamcollsurg.2011.05.017. Epub 2011 Jun 29.

    PMID: 21715189BACKGROUND

  • Oelschlager BK, Pellegrini CA, Hunter J, Soper N, Brunt M, Sheppard B, Jobe B, Polissar N, Mitsumori L, Nelson J, Swanstrom L. Biologic prosthesis reduces recurrence after laparoscopic paraesophageal hernia repair: a multicenter, prospective, randomized trial. Ann Surg. 2006 Oct;244(4):481-90. doi: 10.1097/01.sla.0000237759.42831.03.

    PMID: 16998356BACKGROUND

  • Hashemi M, Peters JH, DeMeester TR, Huprich JE, Quek M, Hagen JA, Crookes PF, Theisen J, DeMeester SR, Sillin LF, Bremner CG. Laparoscopic repair of large type III hiatal hernia: objective followup reveals high recurrence rate. J Am Coll Surg. 2000 May;190(5):553-60; discussion 560-1. doi: 10.1016/s1072-7515(00)00260-x.

    PMID: 10801022RESULT

  • Mattar SG, Bowers SP, Galloway KD, Hunter JG, Smith CD. Long-term outcome of laparoscopic repair of paraesophageal hernia. Surg Endosc. 2002 May;16(5):745-9. doi: 10.1007/s00464-001-8194-7. Epub 2002 Feb 8.

    PMID: 11997814RESULT

MeSH Terms

Conditions

Hernia, Hiatal

Condition Hierarchy (Ancestors)

Hernia, DiaphragmaticInternal HerniaHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Vic Velanovich, MD

    University of South Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2017

First Posted

February 23, 2017

Study Start

February 2, 2016

Primary Completion

April 1, 2018

Study Completion

January 28, 2019

Last Updated

March 28, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)