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Paraesophageal HerniaNCT03058731

ACELL Mesh for Paraesophageal Hernia Repair

An observational study of Paraesophageal Hernia, run by University of South Florida at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Paraesophageal Hernia
What is being tested?
Matristem
Type of treatment
Medical device
How many people
65 participants
Where
1 siteUnited States
Study dates
2 Feb 2016to 28 Jan 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Tampa General Hospital

    Tampa, Florida, 33606

Other trials in United States

About this study

Official title: 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.

Read the 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.
Being tested
Matristem, Control
Medical subject headings
Hernia, Hiatal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MatristemDevice

    Paraesophageal hernia repair with MatriStem Surgical Matrix

  • ControlDevice

    Paraesophageal hernia repair with other biologic mesh

Study groups in NCT03058731
Study groupRoleWhat they receive
MatristemHernia repair with MatriStem Surgical Matrix
Receives: Device: Matristem
ControlOther biological mesh
Receives: Device: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of hernia recurrence

    Measured: 12 months

Secondary outcomes (5)

  1. Mean vertical height of hiatal hernia

    For patients with hiatal hernia recurrence

    Measured: 12 months

  2. Mean cross-sectional area of hiatal hernia

    For patients with hiatal hernia recurrence

    Measured: 12 months

  3. Rate of postoperative complications

    Measured: 12 months

  4. Mean GERD-Health Related QOL score

    Measured: 12 months

  5. Mean SF-36 QOL score

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2017
  2. Study start2 Feb 2016
  3. Primary completion1 Apr 2018
  4. Study completion28 Jan 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Retrospective
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03058731
Sponsor's protocol ID
ACELL01
Status last verified
Mar 2019
First submitted
16 Feb 2017
Last updated
28 Mar 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 21715189

  • 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.

    PubMed 16998356

  • 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.

    PubMed 10801022

  • 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.

    PubMed 11997814

Questions about this trial

What is this clinical trial studying?

An observational study of Paraesophageal Hernia, run by University of South Florida at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of hernia recurrence (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03058731, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2019.

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