Di Buono Giuseppe, Romano Giorgio, Rodolico Vito, Amato Giuseppe, Zanghì Guido, Romano Giorgio, Calò Pietro Giorgio, Agrusa Antonino
Department of Precision Medicine in Medical, Surgical and Critical Care (Me.Pre.C.C.), University of Palermo, Via del Vespro, 129, 90127, Palermo, Italy.
Department PROMISE, Section Pathological Anatomy University of Palermo, Palermo, Italy.
Surg Endosc. 2025 May;39(5):3113-3126. doi: 10.1007/s00464-025-11680-x. Epub 2025 Apr 1.
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.
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.
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.
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.
This study was registered at ClinicalTrials.gov with number NCT06556498.
这项随机、多中心临床试验通过比较Progrip自固定补片与ProFlor 3D动态再生支架，评估腹腔镜双侧腹股沟疝修补术的效果。
纳入年龄在18 - 85岁、临床诊断为双侧原发性腹股沟疝的成年人，采用区组随机化方法将其随机分为两个治疗组（Progrip组或ProFlor组）。在24个月的随访期内评估手术时间、术中和术后并发症、复发率、术后疼痛及生活质量。研究人员和患者对分组情况均未设盲。
2021年1月至2022年6月，150例患者接受了腹腔镜经腹腹膜前疝修补术（TAPP）。18例失访（ProFlor组5例，Progrip组13例）。共分析了132例患者（ProFlor组67例，Progrip组65例）。与Progrip组相比，ProFlor组手术时间更短，术中和术后并发症更少，术后早期疼痛减轻。ProFlor组患者恢复更快，更早恢复日常活动。值得注意的是，ProFlor组患者均未出现慢性疼痛，而Progrip组有10.8%的患者出现了这一并发症。Progrip组有2例患者出现疝复发，而ProFlor组未报告复发情况。
在这项随机试验中，两种器械用于腹腔镜双侧腹股沟疝修补术均被证明是可行且有效的。然而，与Progrip相比，ProFlor支架与术后疼痛减轻、无慢性疼痛以及随访期间无复发相关。虽然这些发现令人鼓舞，但仍需要更大样本量和更长随访期的进一步研究来证实ProFlor支架的潜在益处及其在常规临床实践中的作用。
本研究已在ClinicalTrials.gov注册，注册号为NCT06556498。
