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there are currently two methods for fixation free laparoscopic inguinal hernia repair specifically based on the intrinsic properties of the device used. The Progrip mesh technique leaves the hernia orifice patent and relies on the established principle of strengthening the groin through scar tissue incorporation induced by foreign body reaction. In contrast, the ProFlor concept introduces a 3D dynamic regenerative scaffold that permanently obliterates the defect and regenerates the herniated inguinal barrier. This report presents the outcomes of laparoscopic techniques employing Progrip and ProFlor in randomized clinical trial. The results of this clinical study may have the potential to pave the way for innovative advancements in hernia repair techniques.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ProFlor group | Active Comparator | patients underwent to laparoscopic hernia repair with the use of ProFlor mesh |
|
| Progrip group | Active Comparator | patients underwent to laparoscopic hernia repair with the use of Progrip mesh |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proflor group | Procedure | evaluate the surgical outcomes of patients underwent to laparoscopic inguinal hernia repair with Proflor mesh. |
|
| Measure | Description | Time Frame |
|---|---|---|
| postoperative adverse events | postoperative adverse events. The primary objective of these evaluations was to detect any possible complications that may have arisen, including but not limited to recurrence, hematoma, seroma, testicular swelling, wound infection/abscesses, prosthesis displacement, or any other complication. We used clinical observation and radiological findings to detect these complications. | 30-postoperative days |
| Measure | Description | Time Frame |
|---|---|---|
| Visual analogue score (VAS) | The secondary endpoints included evaluations of postoperative pain. During follow-up control, patients were tasked with completing questionnaires aimed at evaluating their clinical conditions. To assess pain levels during the early stage (until four weeks postop.), the Visual Analogue Score (VAS) was employed. The VAS score is a widely recognized tool that enables patients to rate their pain on a scale from 0 to 10, where 0 signifies no pain and 10 indicates the most severe pain imaginable. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Giuseppe Di Buono | University of Palermo | Principal Investigator |
| Antoninoq Agrusa | University of Palermo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Italy | Palermo | 90127 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40167608 | Derived | Di Buono G, Romano G, Rodolico V, Amato G, Zanghi G, Romano G, Calo PG, Agrusa A. Progrip versus ProFlor: two fixation-free devices for laparoscopic inguinal hernia repair-the Pro/Pro study, a randomized clinical trial. Surg Endosc. 2025 May;39(5):3113-3126. doi: 10.1007/s00464-025-11680-x. Epub 2025 Apr 1. |
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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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we use progrip mesh and proflor mesh in different arms of patients
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Compared progrip mesh with proflor mesh
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| Progrip group | Procedure | evaluate the surgical outcomes of patients underwent to laparoscopic inguinal hernia repair with Progrip mesh. |
|
| 1 - 6- 12 and 24 months |
| Carolinas Comfort Scale (CCS) | The secondary endpoints included evaluations of discomfort and quality of life. During follow-up control, patients were tasked with completing questionnaires aimed at evaluating their clinical conditions. For long-term clinical evaluation starting from four weeks postop, patients were instructed to fill out the Carolinas Comfort Scale questionnaire (CCS), regarded as the optimal scoring system for discomfort, and other postoperative symptoms. The CCS questionnaire offered a more thorough insight into the patient's experience and facilitated the evaluation of their long-term outcomes. The CCS is a 23-itemquestionnaire that quantifies the severity of pain, mesh sensation, and movement limitation from the hernia or surgical site during the following 8 activities: lying down, bending over, sitting up, activities of daily living, coughing or deep breathing (Min. 0 with no discomfort in all activity; Max. 115 with maximum discomfort in all activity) | 1 - 6- 12 and 24 months |