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This investigation will be a double-armed, randomized (Blinded patients and Blinded examiner) prospective study designed to collect perioperative and postoperative data to compare the QOL of ProFlor vs. Lichtenstein inguinal hernia repair.
The primary objectives of this study will be to evaluate the immediate and short-term amount of post-operative pain, the quality of life (QOL), as well as return to normal activities (work) for the two procedures. Carolinas Comfort Scale (CCS) and Visual Analogue Score (VAS) assessments will be held at regular intervals to evaluate these objectives.
The secondary objective of the study is to identify any short-term study related complications/adverse events.
The follow up will be immediately post-operative, post-operative day 1, and 1, 2,and 4 weeks. The first and 4th week's visits are mandatory office visits (if possible). If not available for office visit, a CCS assessment will be mailed or will be conducted via phone.
Up to 50 patients may be enrolled for this study (25 per arm). A report may be generated for presentation at an international meeting such as the AHS, EHS, or APHS if decided by the lead investigator.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ProFlor Hernia Repair System | Active Comparator | A 3-D hernia mesh |
|
| Lichtenstein Hernia Repair | Active Comparator | Using flat polypropylene mesh |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ProFlor Hernia Repair System | Device | The 3-D hernia mesh will be used in the repair of your inguinal hernia. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the immediate and short-term amount of pain. | We will evaluate the immediate and short-term amount of pain using the VAS and Carolinas Comfort Scale (CCS) assessments held at regular intervals. | 1 month |
| Compare the time required for return to normal activities (work). | We will capture the time required to return to normal activities as indicated by the patient. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Identify any short-term related complication/adverse events associated with the procedures. | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Murphy, MD | Healing Hands Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Healing Hands Clinic | Pune | India |
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| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Lichtenstein hernia repair | Device | The standard Lichtenstein hernia repair with flat mesh will be used in the treatment of your inguinal hernia. |
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