Abstract
TRIAL DESIGN: This randomized, multicenter clinical trial evaluates laparoscopic bilateral inguinal hernia repair outcomes by comparing the Progrip self-fixating mesh to the ProFlor 3D dynamic regenerative scaffold. METHODS: Adults aged 18-85 years with clinically diagnosed bilateral primary inguinal hernias were enrolled and randomized into two treatment groups (Progrip or ProFlor) using block randomization. Operative time, intra- and postoperative complications, recurrence rates, postoperative pain, and quality of life were assessed over a 24-month follow-up. The allocation was not blinded to investigators or patients. RESULTS: From January 2021 to June 2022, 150 patients underwent laparoscopic TAPP repair. Eighteen were lost to follow-up (5 in the ProFlor group, 13 in the Progrip group). A total of 132 patients (67 ProFlor, 65 Progrip) were analyzed. The ProFlor group demonstrated shorter operative times, fewer intra- and postoperative complications, and reduced early postoperative pain compared to the Progrip group. Patients in the ProFlor arm achieved faster recovery and earlier return to daily activities. Notably, none of the ProFlor patients experienced chronic pain, whereas 10.8% of Progrip patients developed this complication. Hernia recurrence was observed in 2 Progrip patients, while no recurrences were reported in the ProFlor™ group. CONCLUSION: In this randomized trial, both devices proved feasible and effective for laparoscopic repair of bilateral inguinal hernias. However, the ProFlor scaffold was associated with reduced postoperative pain, absence of chronic pain, and no recurrences during follow-up compared to Progrip. While these findings are encouraging, further studies with larger cohorts and longer-term follow-up are warranted to confirm the potential benefits of the ProFlor scaffold and its role in routine clinical practice. TRIAL REGISTRATION: This study was registered at ClinicalTrials.gov with number NCT06556498.