Hernia, Inguinal
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEULTRAPRO Mesh
Patients who are randomized to this group will received ULTRAPRO Mesh for their hernia repair
DEVICE3DMAX
Patients who are randomized to this group will receive 3DMAX mesh for their hernia repair
OTHEREvaluation
To evaluate the ease of use and time it takes residents to place and perform the surgery using these two different meshes.
Sponsors
New Hanover Regional Medical Center
South East Area Health Education Center, Wilmington, NC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects undergoing laparoscopic repair for the treatment of either single or bilateral inguinal hernias * All surgical residents at New Hanover Regional Medical Center
Exclusion criteria
* Subjects requiring emergency surgery * Pregnant subjects * Subjects under the age of 18 years of age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inguinal Hernia Mesh Insertion Times | During the procedure an average of an hour | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NASA TLX Survey Index Scores | During procedure an average of 1 hour | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 25 |
| 3DMAX Mesh 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 | 25 |
| Total | 50 |
Baseline characteristics
| Characteristic | 3DMAX Mesh | Total | ULTRAPRO Mesh |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 10 Participants | 21 Participants | 11 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 29 Participants | 14 Participants |
| Age, Continuous | 59 years | 61 years | 62 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 23 Participants | 27 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 22 Participants | 21 Participants |
| Region of Enrollment United States | 25 Participants | 50 Participants | 25 Participants |
| Sex: Female, Male Female | 8 Participants | 13 Participants | 5 Participants |
| Sex: Female, Male Male | 17 Participants | 37 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 24 | 0 / 0 |
| other Total, other adverse events | 0 / 24 | 0 / 24 | 0 / 0 |
| serious Total, serious adverse events | 0 / 24 | 0 / 24 | 0 / 0 |
Outcome results
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.
Time frame: During the procedure an average of an hour
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ULTRAPRO Mesh | Inguinal Hernia Mesh Insertion Times | 9.76 Minutes | Standard Deviation 7.24 |
| 3DMAX Mesh | Inguinal Hernia Mesh Insertion Times | 8.70 Minutes | Standard Deviation 5.86 |
p-value: 0.523t-test, 1 sided
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.
Time frame: During procedure an average of 1 hour
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ULTRAPRO Mesh | NASA TLX Survey Index Scores | NASA Mental Demand | 7.63 Score on NASA scale | Standard Deviation 5.07 |
| ULTRAPRO Mesh | NASA TLX Survey Index Scores | NASA Physical Demand | 6.67 Score on NASA scale | Standard Deviation 5.39 |
| ULTRAPRO Mesh | NASA TLX Survey Index Scores | NASA Temporal Demand | 7.46 Score on NASA scale | Standard Deviation 4.95 |
| ULTRAPRO Mesh | NASA TLX Survey Index Scores | NASA Performance | 8.04 Score on NASA scale | Standard Deviation 5.34 |
| 3DMAX Mesh | NASA TLX Survey Index Scores | NASA Performance | 6.54 Score on NASA scale | Standard Deviation 3.48 |
| 3DMAX Mesh | NASA TLX Survey Index Scores | NASA Mental Demand | 8.67 Score on NASA scale | Standard Deviation 4.2 |
| 3DMAX Mesh | NASA TLX Survey Index Scores | NASA Temporal Demand | 8.00 Score on NASA scale | Standard Deviation 4.02 |
| 3DMAX Mesh | NASA TLX Survey Index Scores | NASA Physical Demand | 7.00 Score on NASA scale | Standard Deviation 3.88 |
Comparison: Nasa Mental Demandp-value: 0.371t-test, 1 sided
Comparison: NASA Physical Demandp-value: 0.122t-test, 1 sided
Comparison: NASA Temporal Demandp-value: 0.325t-test, 1 sided
Comparison: NASA Peformancep-value: 0.0451t-test, 1 sided