Strattice in Repair of Inguinal Hernias

Study Overview
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Brief Summary
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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.

Official Title
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Prospective, Randomized, Controlled, Third-Party Blinded Multicenter Evaluation of Strattice/LTM in the Repair of Inguinal Hernias

Conditions
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Hernia, Inguinal

Intervention / Treatment
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* Device: Inguinal hernia repair with Ultrapro
* Device: Inguinal hernia repair with Strattice


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>lightweight polypropylene mesh | Device: Inguinal hernia repair with Ultrapro<br>* surgical mesh (15x15cm) to support Lichtenstein repair<br>* Other names: Ultrapro (Ethicon, Somerville NJ);|
| Active Comparator: 2<br>Strattice | Device: Inguinal hernia repair with Strattice<br>* Surgical mesh (10x16) used to support Lichtenstein repair<br>* Other names: Strattice Reconstructive Tissue Matrix;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline to 3 Months | 
| 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. | Baseline to 6 Months | 
| 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. | Baseline to 12 Months | 
| 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. | Baseline to 24 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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surgical mesh, inguinal hernia repair, chronic groin pain