A Prospective Study to Compare the Clinical Outcomes, Pain and Patient Quality of Life for Hernia Patients
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
1 other identifier
observational
944
1 country
17
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2016
Longer than P75 for all trials
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 19, 2016
CompletedFirst Posted
Study publicly available on registry
March 22, 2016
CompletedStudy Start
First participant enrolled
April 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2022
CompletedMarch 1, 2023
February 1, 2023
6.5 years
February 19, 2016
February 27, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Number of complications observed intraoperatively through 30 days
Number of intraoperative and short-term complications related to hernia repair.
30 days
Number of patient reported complications post 30-days through 3 years post procedure
Number of long-term complications related to hernia repair directly reported by patients
30 days post-procedure to 3 years post-procedure
Secondary Outcomes (3)
Patient reported outcomes on Quality of Life through 1 year
Pre-procedure (baseline) and 30 days through 1 year for Qualify of Life
Incisional or Inguinal Hernia Recurrence through 3 years
30 days post-procedure through 3 years
Patient reported outcomes on post-procedure pain through 3 years
2-4 weeks post-procedure through 3 years post-procedure
Study Arms (3)
Open Hernia Repair
A minimum of 300 patients will be enrolled in the Incisional and Inguinal Hernia open repair surgical procedure
Laparoscopic Hernia Repair
A minimum of 300 patients will be enrolled in the Incisional and Inguinal Hernia laparoscopic repair surgical procedure
Robotic Hernia Repair
A minimum of 300 patients will be enrolled in the Incisional and Inguinal Hernia robotic-assisted laparoscopic repair surgical procedure
Interventions
Patient undergoing Hernia repair using different surgical modalities as per the surgeon's standard of care practice
Eligibility Criteria
At least 900 patients will be enrolled in this post-market study that is planned to be conducted for mainly 2 types of hernia repairs, Incisional hernia repair and inguinal hernia repair ( robotic-assisted, lap and open). Up to 2000 patients may be enrolled. Approximately 450 patients who will undergo inguinal hernia repair across open, laparoscopic or robotic-assisted procedures (\~ 150 patients in each surgical modality) and approximately 450 patients who will undergo incisional hernia repair across open, laparoscopic or robotic-assisted procedures (\~ 150 patients in each surgical modality) will be enrolled in this study at up to thirty (30) study centers
You may qualify if:
- Age 18 years and older
- All patients undergoing either an open, laparoscopic or robotic-assisted
- Incisional or Inguinal Hernia repair procedure
- Non-Emergent Incisional or Inguinal Hernia Repair cases
You may not qualify if:
- Emergent Cases for both Incisional and Inguinal Hernia
- Incisional Hernia related to ostomy formation
- Incisional Hernia requiring component separation (determined pre-operatively or intraoperatively)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Intuitive Surgicallead
- Accelovancecollaborator
Study Sites (17)
Beverly Hills Hernia Center
Beverly Hills, California, 90210, United States
Vanderbilt University Medical Center
Nashville, California, 37232, United States
Kaiser Foundation Research Institute
Oakland, California, 94612, United States
Florida Hospital - Celebration Health
Celebration, Florida, 34747, United States
Baptist Health South Florida
South Miami, Florida, 33143, United States
Southern Illinois Healthcare
Carbondale, Illinois, 62901, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Progressive Surgical Associates
New Lenox, Illinois, 60451, United States
Louisville Surgical Associates
Louisville, Kentucky, 40215, United States
Our Lady of the Lake Regional Medical Center
Baton Rouge, Louisiana, 70808, United States
Mercy Medical Center
Baltimore, Maryland, 21202, United States
Spectrum Health System
Grand Rapids, Michigan, 49503, United States
The Mount Sinai Medical Center
New York, New York, 10029, United States
New Hanover Regional Medical Center
Wilmington, North Carolina, 28403, United States
Hillcrest Medical Center
Tulsa, Oklahoma, 74104, United States
University of Tennessee
Memphis, Tennessee, 38120, United States
The Dallas VA Research Corporation
Dallas, Texas, 75216, United States
Related Publications (2)
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.
PMID: 34031762DERIVEDLeBlanc 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.
PMID: 31669560DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Karl LeBlanc, MD
Surgeon Group of Baton Rouge
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 19, 2016
First Posted
March 22, 2016
Study Start
April 1, 2016
Primary Completion
October 1, 2022
Study Completion
October 1, 2022
Last Updated
March 1, 2023
Record last verified: 2023-02