Trial Outcomes & Findings for Prospective Trial Comparing Two Different Polypropylene Meshes for Inguinal Hernias (NCT NCT01825187)
NCT ID: NCT01825187
Last Updated: 2022-06-14
Results Overview
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.
COMPLETED
NA
75 participants
During the procedure an average of an hour
2022-06-14
Participant Flow
Participant milestones
| Measure |
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
|
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
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
25
|
|
Overall Study
COMPLETED
|
24
|
24
|
24
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prospective Trial Comparing Two Different Polypropylene Meshes for Inguinal Hernias
Baseline characteristics by cohort
| Measure |
ULTRAPRO Mesh
n=25 Participants
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
|
3DMAX Mesh
n=25 Participants
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
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Age, Continuous
|
62 years
n=99 Participants
|
59 years
n=107 Participants
|
61 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
25 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: During the procedure an average of an hourThe 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.
Outcome measures
| Measure |
ULTRAPRO Mesh
n=24 Participants
ULTRAPRO Mesh: Patients randomized to this group received ULTRAPRO Mesh for their hernia repair
|
3DMAX Mesh
n=24 Participants
3DMAX: Patients randomized to this group received 3DMAX mesh for their hernia repair
|
|---|---|---|
|
Inguinal Hernia Mesh Insertion Times
|
9.76 Minutes
Standard Deviation 7.24
|
8.70 Minutes
Standard Deviation 5.86
|
SECONDARY outcome
Timeframe: During procedure an average of 1 hourFollowing 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.
Outcome measures
| Measure |
ULTRAPRO Mesh
n=24 Participants
ULTRAPRO Mesh: Patients randomized to this group received ULTRAPRO Mesh for their hernia repair
|
3DMAX Mesh
n=24 Participants
3DMAX: Patients randomized to this group received 3DMAX mesh for their hernia repair
|
|---|---|---|
|
NASA TLX Survey Index Scores
NASA Performance
|
8.04 Score on NASA scale
Standard Deviation 5.34
|
6.54 Score on NASA scale
Standard Deviation 3.48
|
|
NASA TLX Survey Index Scores
NASA Mental Demand
|
7.63 Score on NASA scale
Standard Deviation 5.07
|
8.67 Score on NASA scale
Standard Deviation 4.20
|
|
NASA TLX Survey Index Scores
NASA Physical Demand
|
6.67 Score on NASA scale
Standard Deviation 5.39
|
7.00 Score on NASA scale
Standard Deviation 3.88
|
|
NASA TLX Survey Index Scores
NASA Temporal Demand
|
7.46 Score on NASA scale
Standard Deviation 4.95
|
8.00 Score on NASA scale
Standard Deviation 4.02
|
Adverse Events
ULTRAPRO Mesh Group
3DMAX Mesh Group
Evaluation of Surgical Residents
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place