A Prospective Study to Compare the Clinical Outcomes, Pain and Patient Quality of Life for Hernia Patients



Status:Recruiting
Conditions:Gastrointestinal, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:3/27/2019
Start Date:April 2016
End Date:December 2021
Contact:Sundeep Master
Email:sundeep.master@intusurg.com

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Trial Summary
Trial Overview
Inclusion Criteria

A Prospective, Multicenter Post-Market Study to Evaluate and Compare the Clinical Outcomes, Pain and Patient Quality of Life After Open, Laparoscopic or Robotic Assisted Hernia (Incisional and Inguinal) Repair

The objective of this prospective, multi-center post-market study is to prospectively collect
uniform, evidence based outcomes for patients undergoing open, laparoscopic or robotic
assisted hernia repair.

The outcomes that will be collected include various routine clinical parameters, short term
patient reported outcomes (quality of life, pain scores) and long term hernia recurrence
information. Patients will be treated according to standard of care at the surgeon's
institution and patients will be followed up to collect information related to complications
information and patient satisfaction associated with the hernia repair procedure.


Inclusion Criteria:

1. Age 18 years and older

2. All patients undergoing either an open, laparoscopic or robotic-assisted

3. Incisional or Inguinal Hernia repair procedure

4. Non-Emergent Incisional or Inguinal Hernia Repair cases

Exclusion Criteria:

1. Emergent Cases for both Incisional and Inguinal Hernia

2. Incisional Hernia related to ostomy formation

3. Incisional Hernia requiring component separation (determined pre-operatively or
intraoperatively)
We found this trial at
17
sites
Spectrum Health System
Grand Rapids, Michigan 49503
Principal Investigator: Amy Banks-Venegoni, MD
Phone: 616-486-6079
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Grand Rapids, MI
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Florida Hospital Celebration Health
400
Celebration, Florida 34747
Principal Investigator: Carlos Ortiz-Ortiz, M.D.
Phone: 407-303-4702
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mi
from
Celebration, FL
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University of Tennessee
920 Madison Ave
Memphis, Tennessee 38163
Principal Investigator: Guy Voeller, MD
Phone: 901-866-8530
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mi
from
Memphis, TN
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Mount Sinai Hospital
1 Gustave L Levy Pl # 271
New York, New York 10029
 (212) 241-6500
Principal Investigator: Brian Jacob, MD
Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
?
mi
from
New York, NY
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Mercy Medical Center
345 St Paul Pl
Baltimore, Maryland 21202
(410) 332-9000
Principal Investigator: Thomas Swope
Mercy Medical Center "Mercy Medical Center" is a hospital located in Baltimore, Maryland. The landmark...
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mi
from
Baltimore, MD
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Our Lady of the Lake Regional Medical Center
Baton Rouge, Louisiana
Principal Investigator: Karl LeBlanc, MD
Phone: 225-765-6547
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mi
from
Baton Rouge, LA
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Beverly Hills Hernia Center
Beverly Hills, California 90210
Principal Investigator: Shirin Towfigh, MD
Phone: 310-358-5020
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mi
from
Beverly Hills, CA
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Southern Illinois Healthcare
305 West Jackson Street
Carbondale, Illinois 62901
Principal Investigator: Adrian Martin, MD
Phone: 314-795-0783
?
mi
from
Carbondale, IL
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Rush University Medical Center
1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Principal Investigator: Keith Millikan, MD
Phone: 312-942-3717
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
?
mi
from
Chicago, IL
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Dallas VA Research Corporation
Dallas, Texas
Principal Investigator: Courtney Balentine, MD
Phone: 214-857-3040
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mi
from
Dallas, TX
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Louisville Surgical Associates
Louisville, Kentucky 40215
Principal Investigator: John Olsofka, MD
Phone: 312-942-6379
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mi
from
Louisville, KY
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Vanderbilt University Medical Center
1211 Medical Center Drive
Nashville, California 37232
Principal Investigator: Richard Pierce, MD
Phone: 615-343-5821
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mi
from
Nashville, CA
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Progressive Surgical Associates
1890 Silver Cross Boulevard
New Lenox, Illinois 60451
Principal Investigator: Reza Gamagami, MD
Phone: 815-717-8730
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mi
from
New Lenox, IL
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Kaiser Foundation Research Institute
1800 Harrison Street
Oakland, California 94612
Principal Investigator: Elliott Brill, MD
Phone: 650-450-3459
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mi
from
Oakland, CA
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Baptist Health South Florida
South Miami, Florida 33143
Principal Investigator: Anthony Gonzalez, MD
Phone: 786-467-2539
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mi
from
South Miami, FL
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Hillcrest Medical Center
Tulsa, Oklahoma 74101
Principal Investigator: Eugene Dickens, MD
Phone: 918-574-0611
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mi
from
Tulsa, OK
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New Hanover Regional Medical Center
Wilmington, North Carolina 28401
Principal Investigator: William Hope, MD
Phone: 910-667-9281
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mi
from
Wilmington, NC
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