Progrip Versus ProFlor: Two Fixation Free Devices for Laparoscopic Inguinal Hernia Repair
NCT Number: NCT06556498
Acronym: ProPro
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Hernia, Inguinal|Laparoscopic Surgery
Interventions: PROCEDURE: Proflor group|PROCEDURE: Progrip group
Sponsor: University of Palermo
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-01-01
Completion Date: 2025-12-31
Locations: Italy, Palermo, 90127, Italy

Summary:
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.

Primary Outcome Measures: 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
Secondary Outcome Measures: 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., 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