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| Name | Class |
|---|---|
| Accelovance | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hernia repair | Procedure | Patient undergoing Hernia repair using different surgical modalities as per the surgeon's standard of care practice |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient reported outcomes on Quality of Life through 1 year | Use of quality of life questionnaires (Carolinas Comfort Scale or HerQles Abdominal Questionnaire) will be used to assess patient qualify of life pre-procedure and post-procedure through 1 year. | Pre-procedure (baseline) and 30 days through 1 year for Qualify of Life |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Karl LeBlanc, MD | Surgeon Group of Baton Rouge | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beverly Hills Hernia Center | Beverly Hills | California | 90210 | United States | ||
| Vanderbilt University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34031762 | Derived | 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. | |
| 31669560 | Derived |
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| Incisional or Inguinal Hernia Recurrence through 3 years |
Number of hernia recurrences for each patient will be patient reported through 3 years post-procedure. |
| 30 days post-procedure through 3 years |
| Patient reported outcomes on post-procedure pain through 3 years | Pain medication taken by patient (type, dosage and quantity of pills) will also be captured through patient reported methods. Unit of measure will be numerical count of pills take | 2-4 weeks post-procedure through 3 years post-procedure |
| 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 |
| 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. |
| ID | Term |
|---|---|
| D006547 | Hernia |
| D000069290 | Incisional Hernia |
| D006552 | Hernia, Inguinal |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D046449 | Hernia, Abdominal |
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| ID | Term |
|---|---|
| D059685 | Herniorrhaphy |
| ID | Term |
|---|---|
| D019651 | Plastic Surgery Procedures |
| D013514 | Surgical Procedures, Operative |
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