Hernia, Inguinal
Conditions
Keywords
Mesh, Repair, Peritoneal
Brief summary
Investigators are testing whether tacking mesh or self-fixating mesh used for inguinal hernia repair makes any difference in short-term pain or return to normal activities following the operation. Other studies have shown no significant difference in hernia recurrence rate when metal tacks are not used to hold the mesh in place.
Detailed description
Participants will be placed into two groups. One group of participants will have mesh tacked into place for their hernia repairs. The other group will have self-fixating mesh into place. Both groups will have a piece of mesh that will widely cover the hernia defect. Before surgery, the participant will be asked to rate discomfort on a 0-10 scale. Zero stands for no pain and 10 is the worst pain they can imagine. Investigators will record information about general medical condition, medications and activity level. During the operation information will be recorded about the pain medicines the participant may receive. In the recovery room the participant will be asked to rate their pain on the 0-10 scale and more information will be recorded about any additional pain medicines that they may receive and assess activity level. Following surgery, Investigators will contact the participants by survey to obtain more information about pain level, medication use, and activity level.
Interventions
DEVICEPROLENE Polypropylene Tacking Mesh
Prolene mesh is a polypropylene plastic mesh (10 x 15 cm) implant fixed with titanium tacks
DEVICEProGrip Self-fixating Mesh
ProGrip™ self-fixating mesh is a tack-free fixation mesh for use in open & laparoscopic hernia repairs. It is composed of absorbable Monofilament Polylactic Acid micro grips on one surface integrated with a lightweight Monofilament Polyethylene Terephthalate. The micro grips act as a kind of Velcro to the soft tissue surfaces resulting in self-fixation
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
\- All patients regardless of sex or age who were diagnosed with a inguinal hernia and underwent a totally extraperitoneal (TEP) inguinal hernia repair at the Mayo Clinic in Rochester, Minnesota from June 2013 - June 2014.
Exclusion criteria
\- Patients who did not elect to undergo a hernia repair or who elected to undergo a different type of hernia repair instead of a TEP procedure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Operative Time | First incision to closure, approximately one hour | Length of time needed to complete surgery. |
| Number of Participants With Early Postoperative Complications | Within 30 days | Any complication which occurred within 30 days after the operation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score at Baseline | baseline | Participants were asked to rate their level of pain on a Likert scale (0 through 5; 0=no pain, 5=severe pain). |
| Pain Score at One Week | One Week Postoperative | Participants were asked to rate their level of pain on a Likert scale (0 through 5; 0=no pain, 5=severe pain). |
| Pain Score at Four Weeks | Four Weeks Postoperative | Participants were asked to rate their level of pain on a Likert scale (0 through 5; 0=no pain, 5=severe pain). |
Countries
United States
Participant flow
Recruitment details
Participants were recruited at the Mayo Clinic in Rochester, Minnesota from June 2013 to June 2014.
Participants by arm
| Arm | Count |
|---|---|
| PROLENE Polypropylene Tacking Mesh Participants will be randomized to Tacking Mesh for their inguinal hernia surgery.
PROLENE Polypropylene Tacking Mesh: Prolene mesh is a polypropylene plastic mesh (10 x 15 cm) implant fixed with titanium tacks | 19 |
| ProGrip Self-fixating Mesh Participants will be randomized to Self-fixing mesh for their inguinal hernia surgery
ProGrip Self-fixating Mesh: ProGrip™ self-fixating mesh is a tack-free fixation mesh for use in open & laparoscopic hernia repairs. It is composed of absorbable Monofilament Polylactic Acid micro grips on one surface integrated with a lightweight Monofilament Polyethylene Terephthalate. The micro grips act as a kind of Velcro to the soft tissue surfaces resulting in self-fixation | 19 |
| Total | 38 |
Baseline characteristics
| Characteristic | PROLENE Polypropylene Tacking Mesh | ProGrip Self-fixating Mesh | Total |
|---|---|---|---|
| Age, Continuous | 58 years STANDARD_DEVIATION 11 | 55 years STANDARD_DEVIATION 11 | 55 years STANDARD_DEVIATION 11 |
| Body Mass Index (BMI) | 30 kg/m^2 STANDARD_DEVIATION 10 | 30 kg/m^2 STANDARD_DEVIATION 4 | 30 kg/m^2 STANDARD_DEVIATION 9 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 19 participants | 19 participants | 38 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 19 Participants | 19 Participants | 38 Participants |
| Site of Hernia Bilateral | 16 Participants | 11 Participants | 27 Participants |
| Site of Hernia Unilateral | 3 Participants | 8 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 19 |
| other Total, other adverse events | 1 / 19 | 2 / 19 |
| serious Total, serious adverse events | 2 / 19 | 1 / 19 |
Outcome results
Primary
Mean Operative Time
Length of time needed to complete surgery.
Time frame: First incision to closure, approximately one hour
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PROLENE Polypropylene Tacking Mesh | Mean Operative Time | Bilateral | 69 minutes | Standard Deviation 6.5 |
| PROLENE Polypropylene Tacking Mesh | Mean Operative Time | Unilateral | 40 minutes | Standard Deviation 12 |
| ProGrip Self-fixating Mesh | Mean Operative Time | Bilateral | 84 minutes | Standard Deviation 7.8 |
| ProGrip Self-fixating Mesh | Mean Operative Time | Unilateral | 66 minutes | Standard Deviation 7 |
Comparison: Comparison between groups for bilateral operative time.p-value: 0.17t-test, 2 sided
Comparison: Comparison between groups for unilateral operative time.p-value: 0.09t-test, 2 sided
Primary
Number of Participants With Early Postoperative Complications
Any complication which occurred within 30 days after the operation.
Time frame: Within 30 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PROLENE Polypropylene Tacking Mesh | Number of Participants With Early Postoperative Complications | Overnight admittance to hospital | 2 participants |
| PROLENE Polypropylene Tacking Mesh | Number of Participants With Early Postoperative Complications | Urinary retention | 1 participants |
| PROLENE Polypropylene Tacking Mesh | Number of Participants With Early Postoperative Complications | Recurrence of hernia | 0 participants |
| PROLENE Polypropylene Tacking Mesh | Number of Participants With Early Postoperative Complications | Skin infection | 1 participants |
| ProGrip Self-fixating Mesh | Number of Participants With Early Postoperative Complications | Recurrence of hernia | 1 participants |
| ProGrip Self-fixating Mesh | Number of Participants With Early Postoperative Complications | Overnight admittance to hospital | 1 participants |
| ProGrip Self-fixating Mesh | Number of Participants With Early Postoperative Complications | Urinary retention | 1 participants |
| ProGrip Self-fixating Mesh | Number of Participants With Early Postoperative Complications | Skin infection | 0 participants |
Secondary
Pain Score at Baseline
Participants were asked to rate their level of pain on a Likert scale (0 through 5; 0=no pain, 5=severe pain).
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PROLENE Polypropylene Tacking Mesh | Pain Score at Baseline | 1.13 units on a scale | Standard Deviation 1.196 |
| ProGrip Self-fixating Mesh | Pain Score at Baseline | 1.5 units on a scale | Standard Deviation 1.29 |
Secondary
Pain Score at Four Weeks
Participants were asked to rate their level of pain on a Likert scale (0 through 5; 0=no pain, 5=severe pain).
Time frame: Four Weeks Postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PROLENE Polypropylene Tacking Mesh | Pain Score at Four Weeks | 0.1 units on a scale | Standard Deviation 0.236 |
| ProGrip Self-fixating Mesh | Pain Score at Four Weeks | 0.3 units on a scale | Standard Deviation 0.757 |
Secondary
Pain Score at One Week
Participants were asked to rate their level of pain on a Likert scale (0 through 5; 0=no pain, 5=severe pain).
Time frame: One Week Postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PROLENE Polypropylene Tacking Mesh | Pain Score at One Week | 1.1 units on a scale | Standard Deviation 0.904 |
| ProGrip Self-fixating Mesh | Pain Score at One Week | 0.8 units on a scale | Standard Deviation 0.747 |
Comparison: A p-value of 0.05 was considered statistically significant.p-value: 0.02t-test, 2 sided