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| Name | Class |
|---|---|
| New Hanover Regional Medical Center | OTHER |
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The purpose of this research study is to measure the clinical effectiveness of two different polypropylene meshes used for laparoscopic inguinal hernias by evaluating subjects' length of hospital stay, perioperative complications, recurrence rate, pain score, comfort level and postoperative quality of life. A secondary goal of the study is to evaluate the ease of use and time it takes surgical residents to place the mesh and perform the surgery using these two different meshes.
Inguinal hernia repair is one of the most common operations performed by general surgeons in the world. There are two main ways to repair an inguinal hernia, open or laparoscopic. Open compared to laparoscopic, is more invasive and leads to more scarring and longer recovery periods. Laparoscopic repair is done by making a small cut in or just below the umbilicus and has become an accepted standard for inguinal hernia repair and has become the technique of choice for recurrent inguinal hernias.
During laparoscopic repair, the placement of a prosthetic mesh aids in reinforcing the abdominal wall and allowing for tension free repair. Meshes also helps to lower the recurrence rate. The most safe and effective type of mesh prosthesis currently being used in laparoscopic inguinal hernia repairs are polypropylene meshes. There is some emerging evidence that "lighter weight" forms of polypropylene meshes may improve quality of life outcomes following surgery for inguinal hernias. Further evaluation is needed to support this evidence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group 1 | Active Comparator | Patients in this group will be randomized to receive the ULTRAPRO mesh |
|
| Treatment Group 2 | Active Comparator | Patients in this group will be randomized to receive the 3DMAX Mesh |
|
| Evaluation of Surgical Residents | Other | Surgical residents will be evaluated on the ease of use and the amount of time it takes for them to perform the surgery using these two different meshes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ULTRAPRO Mesh | Device | Patients who are randomized to this group will received ULTRAPRO Mesh for their hernia repair |
|
| Measure | Description | Time Frame |
|---|---|---|
| Inguinal Hernia Mesh Insertion Times | The primary outcome measure was a comparison of mesh insertion times and were tested using a 2 × 2 ANOVA on the ranked times. Timing of the mesh placement was documented, which included time from mesh insertion in the trocar until completion of mesh fixation. Laparoscopic fixation was performed by placing four tacks; two in the pubic bone, one medial, and one lateral on the upper portion of the mesh. The types of tacks used were AbsorbaTack™ (Medtronics), sutures, CapSure™ (CR Bard) and OptiFix™ (CR Bard). Timing of mesh placement in robotic repairs included mesh placement and the time to place three suture fixation points; one at the pubis, one at the anterior, and 1 at the lateral abdominal wall at the top of the mesh. | During the procedure an average of an hour |
| Measure | Description | Time Frame |
|---|---|---|
| NASA TLX Survey Index Scores | Following surgery, the Hart and Staveland's NASA Task Load Index (TLX) survey was completed by the surgeon to evaluate the surgeon's perceived difficulty and success of the operation. Scale ranges from very low (0) to very high (20) on a 20 point scale (0-20 points). For all outcome measures except performance, 0 indicates the worst outcome and 20 indicates the best outcome. For performance, 0 indicates perfect and 20 indicates failure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William W Hope, MD | South East Area Health Education Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Hanover Regional Medical Center | Wilmington | North Carolina | 28401 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32232645 | Derived | Bilezikian JA, Tenzel PL, Johnson RG, Powers WF 4th, Hope WW. A preliminary evaluation of two different meshes in minimally invasive inguinal hernia surgery. Surg Endosc. 2021 Mar;35(3):1342-1347. doi: 10.1007/s00464-020-07512-9. Epub 2020 Mar 30. |
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| ID | Title | Description |
|---|---|---|
| FG000 | ULTRAPRO Mesh Group | Patients in this group will be randomized to receive the ULTRAPRO mesh ULTRAPRO Mesh: Patients who are randomized to this group will received ULTRAPRO Mesh for their hernia repair |
| FG001 | 3DMAX Mesh Group | Patients in this group will be randomized to receive the 3DMAX Mesh 3DMAX: Patients who are randomized to this group will receive 3DMAX mesh for their hernia repair |
| FG002 | Evaluation of Surgical Residents | Surgical residents will be evaluated on the ease of use and the amount of time it takes for them to perform the surgery using these two different meshes. Evaluation: To evaluate the ease of use and time it takes residents to place and perform the surgery using these two different meshes. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
No Baseline Measure data was collected from any Surgical Residents
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| ID | Title | Description |
|---|---|---|
| BG000 | ULTRAPRO Mesh | Patients in this group will be randomized to receive the ULTRAPRO mesh ULTRAPRO Mesh: Patients who are randomized to this group will received ULTRAPRO Mesh for their hernia repair |
| BG001 | 3DMAX Mesh |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Inguinal Hernia Mesh Insertion Times | The primary outcome measure was a comparison of mesh insertion times and were tested using a 2 × 2 ANOVA on the ranked times. Timing of the mesh placement was documented, which included time from mesh insertion in the trocar until completion of mesh fixation. Laparoscopic fixation was performed by placing four tacks; two in the pubic bone, one medial, and one lateral on the upper portion of the mesh. The types of tacks used were AbsorbaTack™ (Medtronics), sutures, CapSure™ (CR Bard) and OptiFix™ (CR Bard). Timing of mesh placement in robotic repairs included mesh placement and the time to place three suture fixation points; one at the pubis, one at the anterior, and 1 at the lateral abdominal wall at the top of the mesh. | Posted | Mean | Standard Deviation | Minutes | During the procedure an average of an hour |
|
Followed participants for AEs up to 2 years following the procedure.
Evaluation of Surgical Residents Group for All-Cause Mortality, Adverse Events, and Other Adverse Events were not monitored/assessed for Surgical Residents.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ULTRAPRO Mesh Group | Patients in this group will be randomized to receive the ULTRAPRO mesh ULTRAPRO Mesh: Patients who are randomized to this group will received ULTRAPRO Mesh for their hernia repair |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. William Hope | New Hanover Regional medical Center | (910)667-9233 | 667 | william.hope@nhrmc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 8, 2013 | Jun 8, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 21, 2016 | Aug 27, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 3DMAX | Device | Patients who are randomized to this group will receive 3DMAX mesh for their hernia repair |
|
| Evaluation | Other | To evaluate the ease of use and time it takes residents to place and perform the surgery using these two different meshes. |
|
| During procedure an average of 1 hour |
Patients in this group will be randomized to receive the 3DMAX Mesh
3DMAX: Patients who are randomized to this group will receive 3DMAX mesh for their hernia repair
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | 3DMAX Mesh | 3DMAX: Patients randomized to this group received 3DMAX mesh for their hernia repair |
|
|
|
| Secondary | NASA TLX Survey Index Scores | Following surgery, the Hart and Staveland's NASA Task Load Index (TLX) survey was completed by the surgeon to evaluate the surgeon's perceived difficulty and success of the operation. Scale ranges from very low (0) to very high (20) on a 20 point scale (0-20 points). For all outcome measures except performance, 0 indicates the worst outcome and 20 indicates the best outcome. For performance, 0 indicates perfect and 20 indicates failure. | Posted | Mean | Standard Deviation | Score on NASA scale | During procedure an average of 1 hour |
|
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | 3DMAX Mesh Group | Patients in this group will be randomized to receive the 3DMAX Mesh 3DMAX: Patients who are randomized to this group will receive 3DMAX mesh for their hernia repair | 0 | 24 | 0 | 24 | 0 | 24 |
| EG002 | Evaluation of Surgical Residents | Surgical residents will be evaluated on the ease of use and the amount of time it takes for them to perform the surgery using these two different meshes. Evaluation: To evaluate the ease of use and time it takes residents to place and perform the surgery using these two different meshes. | 0 | 0 | 0 | 0 | 0 | 0 |
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| NASA Temporal Demand |
|
| NASA Performance |
|
| 0.122 |
| Superiority |
| NASA Temporal Demand | t-test, 1 sided | 0.325 | Superiority |
| NASA Peformance | t-test, 1 sided | 0.0451 | Superiority |