Hernia, Inguinal
Conditions
Keywords
surgical mesh, inguinal hernia repair, chronic groin pain
Brief summary
This is a prospective, randomized, controlled, third-party blinded, multicenter, interventional evaluation of inguinal hernia repair comparing Strattice to light weight polypropylene mesh. Performance and outcomes measures to be compared include postoperative resumption of activities of daily living, nature and incidence of short- and long-term pain and complications, and incidence of hernia recurrence.
Interventions
DEVICEInguinal hernia repair with Ultrapro
surgical mesh (15x15cm) to support Lichtenstein repair
DEVICEInguinal hernia repair with Strattice
Surgical mesh (10x16) used to support Lichtenstein repair
Sponsors
LifeCell
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adult male * symptomatic and palpable inguinal hernia * open, elective, primary unilateral inguinal hernia repair
Exclusion criteria
* bilateral inguinal hernia repair * BMI \>35 * chronic immunosuppression, active chemo/radiation therapy, uncontrolled diabetes, severe liver disease or COPD * chronic prostatitis, orchitis, testicular pain * local or systemic infection at time of repair * known collagen disorder * chronic pain syndrome or under active pain management
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Activities Assessment Scale at 3 Months | Baseline to 3 Months | The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from No difficulty = 1 to Not able to do it = 5. The AAS has three subscales: sedentary activities (items 1-4); ambulatory activities (items 6-8); work/exercise activities (items 11-13). The AAS total and subscale scores are transformed to produce a range of 0-100, with higher values indicating greater functional activity. Subjects completed the assessment at baseline, 3 months, 6 months, 12 months and 24 months. It is the change from baseline to 3, 6, 12 and 24 months which is the primary outcome measure (Baseline calculated value minus time point calculated value). Therefore, a negative number indicates an increase in activity from baseline. |
| Change From Baseline in Activities Assessment Scale at 6 Months | Baseline to 6 Months | The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from No difficulty to Not able to do it. The AAS has three subscales: sedentary activities (items 1-4); ambulatory activities (items 6-8); work/exercise activities (items 11-13). The AAS total and subscale scores are transformed to produce a range of 0-100, with higher values indicating greater functional activity. Subjects completed the assessment at baseline, 3 months, 6 months, 12 months and 24 months. It is the change from baseline to 3, 6, 12 and 24 months which is the primary outcome measure (Baseline calculated value minus time point calculated value). Therefore, a negative number indicates an increase in activity from baseline. |
| Change From Baseline in Activities Assessment Scale at 12 Months | Baseline to 12 Months | The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from No difficulty to Not able to do it. The AAS has three subscales: sedentary activities (items 1-4); ambulatory activities (items 6-8); work/exercise activities (items 11-13). The AAS total and subscale scores are transformed to produce a range of 0-100, with higher values indicating greater functional activity. Subjects completed the assessment at baseline, 3 months, 6 months, 12 months and 24 months. It is the change from baseline to 3, 6, 12 and 24 months which is the primary outcome measure (Baseline calculated value minus time point calculated value). Therefore, a negative number indicates an increase in activity from baseline. |
| Change From Baseline in Activities Assessment Scale at 24 Months | Baseline to 24 Months | The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from No difficulty to Not able to do it. The AAS has three subscales: sedentary activities (items 1-4); ambulatory activities (items 6-8); work/exercise activities (items 11-13). The AAS total and subscale scores are transformed to produce a range of 0-100, with higher values indicating greater functional activity. Subjects completed the assessment at baseline, 3 months, 6 months, 12 months and 24 months. It is the change from baseline to 3, 6, 12 and 24 months which is the primary outcome measure (Baseline calculated value minus time point calculated value). Therefore, a negative number indicates an increase in activity from baseline. |
Countries
United States
Participant flow
Recruitment details
First subject was enrolled on April 11, 2008 and last subject was enrolled on February 12, 2010.
Participants by arm
| Arm | Count |
|---|---|
| 1lightweight Polypropylene Mesh(Utilized for Inguinal Hernia r lightweight polypropylene mesh | 88 |
| 2Strattice (Utilized for Inguinal Hernia Repair) Strattice | 84 |
| Total | 172 |
Baseline characteristics
| Characteristic | 1lightweight Polypropylene Mesh(Utilized for Inguinal Hernia r | 2Strattice (Utilized for Inguinal Hernia Repair) | Total |
|---|---|---|---|
| Age, Continuous | 56.3 years STANDARD_DEVIATION 13.78 | 55.2 years STANDARD_DEVIATION 14.53 | 55.8 years STANDARD_DEVIATION 14.12 |
| Region of Enrollment United States | 88 participants | 84 participants | 172 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 88 Participants | 84 Participants | 172 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 47 / 88 | 49 / 84 |
| serious Total, serious adverse events | 2 / 88 | 4 / 84 |
Outcome results
Primary
Change From Baseline in Activities Assessment Scale at 12 Months
The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from No difficulty to Not able to do it. The AAS has three subscales: sedentary activities (items 1-4); ambulatory activities (items 6-8); work/exercise activities (items 11-13). The AAS total and subscale scores are transformed to produce a range of 0-100, with higher values indicating greater functional activity. Subjects completed the assessment at baseline, 3 months, 6 months, 12 months and 24 months. It is the change from baseline to 3, 6, 12 and 24 months which is the primary outcome measure (Baseline calculated value minus time point calculated value). Therefore, a negative number indicates an increase in activity from baseline.
Time frame: Baseline to 12 Months
Population: Of the 88 participants in Arm 1 who started the study, 83 completed the Activities Assessment Scale at 12 months. Of the 84 participants in Arm 2 who started the study, 70 completed the Activities Assessment Scale at 12 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1lightweight Polypropylene Mesh(Utilized for Inguinal Hernia r | Change From Baseline in Activities Assessment Scale at 12 Months | -8.78 units on a scale | Standard Deviation 9.221 |
| 2Strattice (Utilized for Inguinal Hernia Repair) | Change From Baseline in Activities Assessment Scale at 12 Months | -7.61 units on a scale | Standard Deviation 9.059 |
Primary
Change From Baseline in Activities Assessment Scale at 24 Months
The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from No difficulty to Not able to do it. The AAS has three subscales: sedentary activities (items 1-4); ambulatory activities (items 6-8); work/exercise activities (items 11-13). The AAS total and subscale scores are transformed to produce a range of 0-100, with higher values indicating greater functional activity. Subjects completed the assessment at baseline, 3 months, 6 months, 12 months and 24 months. It is the change from baseline to 3, 6, 12 and 24 months which is the primary outcome measure (Baseline calculated value minus time point calculated value). Therefore, a negative number indicates an increase in activity from baseline.
Time frame: Baseline to 24 Months
Population: Of the 88 participants in Arm 1 who started the study, 75 completed the Activities Assessment Scale at 24 months. Of the 84 participants in Arm 2 who started the study, 57 completed the Activities Assessment Scale at 24 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1lightweight Polypropylene Mesh(Utilized for Inguinal Hernia r | Change From Baseline in Activities Assessment Scale at 24 Months | -7.57 units on a scale | Standard Deviation 8.098 |
| 2Strattice (Utilized for Inguinal Hernia Repair) | Change From Baseline in Activities Assessment Scale at 24 Months | -7.53 units on a scale | Standard Deviation 9.356 |
Primary
Change From Baseline in Activities Assessment Scale at 3 Months
The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from No difficulty = 1 to Not able to do it = 5. The AAS has three subscales: sedentary activities (items 1-4); ambulatory activities (items 6-8); work/exercise activities (items 11-13). The AAS total and subscale scores are transformed to produce a range of 0-100, with higher values indicating greater functional activity. Subjects completed the assessment at baseline, 3 months, 6 months, 12 months and 24 months. It is the change from baseline to 3, 6, 12 and 24 months which is the primary outcome measure (Baseline calculated value minus time point calculated value). Therefore, a negative number indicates an increase in activity from baseline.
Time frame: Baseline to 3 Months
Population: Of the 88 participants in Arm 1 who started the study, 81 completed the Activities Assessment Scale at 3 months. Of the 84 participants in Arm 2 who started the study, 77 completed the Activities Assessment Scale at 3 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1lightweight Polypropylene Mesh(Utilized for Inguinal Hernia r | Change From Baseline in Activities Assessment Scale at 3 Months | -7.49 units on a scale | Standard Deviation 8.961 |
| 2Strattice (Utilized for Inguinal Hernia Repair) | Change From Baseline in Activities Assessment Scale at 3 Months | -6.12 units on a scale | Standard Deviation 8.666 |
Primary
Change From Baseline in Activities Assessment Scale at 6 Months
The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from No difficulty to Not able to do it. The AAS has three subscales: sedentary activities (items 1-4); ambulatory activities (items 6-8); work/exercise activities (items 11-13). The AAS total and subscale scores are transformed to produce a range of 0-100, with higher values indicating greater functional activity. Subjects completed the assessment at baseline, 3 months, 6 months, 12 months and 24 months. It is the change from baseline to 3, 6, 12 and 24 months which is the primary outcome measure (Baseline calculated value minus time point calculated value). Therefore, a negative number indicates an increase in activity from baseline.
Time frame: Baseline to 6 Months
Population: Of the 88 participants in Arm 1 who started the study, 83 completed the Activities Assessment Scale at 6 months. Of the 84 participants in Arm 2 who started the study, 70 completed the Activities Assessment Scale at 6 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1lightweight Polypropylene Mesh(Utilized for Inguinal Hernia r | Change From Baseline in Activities Assessment Scale at 6 Months | -8.17 units on a scale | Standard Deviation 9.475 |
| 2Strattice (Utilized for Inguinal Hernia Repair) | Change From Baseline in Activities Assessment Scale at 6 Months | -7.20 units on a scale | Standard Deviation 8.818 |