A Prospective Study to Compare the Clinical Outcomes, Pain and Patient Quality of Life for Hernia Patients
NCT ID: NCT02715622
Last Updated: 2023-03-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
944 participants
OBSERVATIONAL
2016-04-30
2022-10-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Open Hernia Repair
A minimum of 300 patients will be enrolled in the Incisional and Inguinal Hernia open repair surgical procedure
Hernia repair
Patient undergoing Hernia repair using different surgical modalities as per the surgeon's standard of care practice
Laparoscopic Hernia Repair
A minimum of 300 patients will be enrolled in the Incisional and Inguinal Hernia laparoscopic repair surgical procedure
Hernia repair
Patient undergoing Hernia repair using different surgical modalities as per the surgeon's standard of care practice
Robotic Hernia Repair
A minimum of 300 patients will be enrolled in the Incisional and Inguinal Hernia robotic-assisted laparoscopic repair surgical procedure
Hernia repair
Patient undergoing Hernia repair using different surgical modalities as per the surgeon's standard of care practice
Interventions
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Hernia repair
Patient undergoing Hernia repair using different surgical modalities as per the surgeon's standard of care practice
Eligibility Criteria
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Inclusion Criteria
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
2. Incisional Hernia related to ostomy formation
3. Incisional Hernia requiring component separation (determined pre-operatively or intraoperatively)
18 Years
ALL
No
Sponsors
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Accelovance
INDUSTRY
Intuitive Surgical
INDUSTRY
Responsible Party
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Principal Investigators
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Karl LeBlanc, MD
Role: STUDY_CHAIR
Surgeon Group of Baton Rouge
Locations
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Beverly Hills Hernia Center
Beverly Hills, California, United States
Vanderbilt University Medical Center
Nashville, California, United States
Kaiser Foundation Research Institute
Oakland, California, United States
Florida Hospital - Celebration Health
Celebration, Florida, United States
Baptist Health South Florida
South Miami, Florida, United States
Southern Illinois Healthcare
Carbondale, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
Progressive Surgical Associates
New Lenox, Illinois, United States
Louisville Surgical Associates
Louisville, Kentucky, United States
Our Lady of the Lake Regional Medical Center
Baton Rouge, Louisiana, United States
Mercy Medical Center
Baltimore, Maryland, United States
Spectrum Health System
Grand Rapids, Michigan, United States
The Mount Sinai Medical Center
New York, New York, United States
New Hanover Regional Medical Center
Wilmington, North Carolina, United States
Hillcrest Medical Center
Tulsa, Oklahoma, United States
University of Tennessee
Memphis, Tennessee, United States
The Dallas VA Research Corporation
Dallas, Texas, United States
Countries
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References
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LeBlanc KA, Gonzalez A, Dickens E, Olsofka J, Ortiz-Ortiz C, Verdeja JC, Pierce R; Prospective Hernia Study Group. Robotic-assisted, laparoscopic, and open incisional hernia repair: early outcomes from the Prospective Hernia Study. Hernia. 2021 Aug;25(4):1071-1082. doi: 10.1007/s10029-021-02381-0. Epub 2021 May 24.
LeBlanc KA. Design of a comparative outcome analysis of open, laparoscopic, or robotic-assisted incisional or inguinal hernia repair utilizing surgeon experience and a novel follow-up model. Contemp Clin Trials. 2019 Nov;86:105853. doi: 10.1016/j.cct.2019.105853. Epub 2019 Oct 25.
Other Identifiers
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ISI-PHS-2016
Identifier Type: -
Identifier Source: org_study_id
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