An interventional study of ULTRAPRO Mesh and 3DMAX in Hernia, Inguinal, sponsored by South East Area Health Education Center, Wilmington, NC. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-14.
Sponsored by South East Area Health Education Center, Wilmington, NC · Not applicable, Interventional, and Treatment
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.
1,096 studies on the registry are indexed under Hernia; 132 are open to participants now.
This study's enrollment of 75 is close to the median of 80 across 739 interventional studies indexed under Hernia.
Browse Hernia studies →South East Area Health Education Center, Wilmington, NC is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients in this group will be randomized to receive the ULTRAPRO mesh
Device: ULTRAPRO Mesh
Patients in this group will be randomized to receive the 3DMAX Mesh
Device: 3DMAX
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.
Other: Evaluation
Patients who are randomized to this group will received ULTRAPRO Mesh for their hernia repair
Patients who are randomized to this group will receive 3DMAX mesh for their hernia repair
To evaluate the ease of use and time it takes residents to place and perform the surgery using these two different meshes.
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.
Time frame: During the procedure an average of an hour
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.
Time frame: During procedure an average of 1 hour
| Milestone | ULTRAPRO Mesh Group | 3DMAX Mesh Group | Evaluation of Surgical Residents |
|---|---|---|---|
| Started | 25 | 25 | 25 |
| Completed | 24 | 24 | 24 |
| Not completed | 1 | 1 | 1 |
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.
| Minutes | ULTRAPRO Mesh | 3DMAX Mesh |
|---|---|---|
| Inguinal Hernia Mesh Insertion Times | 9.76 ± 7.24 | 8.70 ± 5.86 |
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.
| Score on NASA scale | ULTRAPRO Mesh Group | 3DMAX Mesh Group |
|---|---|---|
| NASA Mental Demand | 7.63 ± 5.07 | 8.67 ± 4.20 |
| NASA Physical Demand | 6.67 ± 5.39 | 7.00 ± 3.88 |
| NASA Temporal Demand | 7.46 ± 4.95 | 8.00 ± 4.02 |
| NASA Performance | 8.04 ± 5.34 | 6.54 ± 3.48 |
Collected over Followed participants for AEs up to 2 years following the procedure.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ULTRAPRO Mesh Group | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) |
| 3DMAX Mesh Group | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) |
| Evaluation of Surgical Residents | — | — | — |
No Baseline Measure data was collected from any Surgical Residents
| Age, Categorical(Participants) | ULTRAPRO Mesh | 3DMAX Mesh | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 14 | 15 | 29 |
| >=65 years | 11 | 10 | 21 |
| Age, Continuous(years) | ULTRAPRO Mesh | 3DMAX Mesh | Total |
|---|---|---|---|
| Median | 62 (37 to 87) | 59 (30 to 86) | 61 (30 to 87) |
| Sex: Female, Male(Participants) | ULTRAPRO Mesh | 3DMAX Mesh | Total |
|---|---|---|---|
| Female | 5 | 8 | 13 |
| Male | 20 | 17 | 37 |
| Race (NIH/OMB)(Participants) | ULTRAPRO Mesh | 3DMAX Mesh | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 4 | 23 | 27 |
| White | 21 | 1 | 22 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Region of Enrollment(Participants) | ULTRAPRO Mesh | 3DMAX Mesh | Total |
|---|---|---|---|
| United States | 25 | 25 | 50 |
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South East Area Health Education Center, Wilmington, NC