Dams Anne, Vankeirsbilck Joost, Poelmans Stephan, Kerschaever Ivan, Borreman Philippe, Berwouts Luc, De Mulder Wim, Colle Julien, Beunis Anthony, Dhooghe Vicky, Van De Winkel Nele, Allaeys Mathias, Ruyssers Michael, Haesen Dorien, Van der Speeten Kurt
Department of Abdominal Surgery, Ziekenhuis Oost-Limburg, Genk, Belgium.
Department of General and Abdominal Surgery, Regional Hospital Heilig Hart, Tienen, Belgium.
Surg Endosc. 2023 Dec;37(12):9105-9115. doi: 10.1007/s00464-023-10439-6. Epub 2023 Oct 5.
Inguinal hernia repair is among the most frequently performed surgical procedures. Alternatives to penetrating mesh fixation, such as surgical glue, are being investigated for their potential benefit in reducing chronic pain. The aim of this study was to assess the efficacy of the n-hexyl cyanoacrylate glue Ifabond™ for mesh fixation in laparoscopic inguinal hernia repair.
This prospective, multicenter, single-arm study collected data from laparoscopic inguinal hernia repairs using Ifabond™ (Peters Surgical, Boulogne-Billancourt Cedex, France) and a standard [Promesh® SURG ST (Peters Surgical)/Biomesh® P1 (Cousin Biotech, Wervicq-Sud, France)] or lightweight [Promesh® SURG LI (Peters Surgical)/Premium® Implant (Cousin Biotech)] polypropylene mesh. The primary endpoint was postoperative pain [100-scale Visual Analog Scale (VAS)]. Secondary endpoints were complications, hernia recurrences, and quality of life (QoL) (EQ-5D-3L health index and EQ-VAS). Patients were followed up at 5 weeks and 12 months after surgery.
Six-hundred and thirteen patients underwent laparoscopic inguinal hernia repair. Postoperative pain decreased at 5-week (3.97 ± 10.04; p < 0.0001) and 12-month (3.83 ± 11.26; p < 0.0001) follow-up compared with before surgery (26.96 ± 19.42). One hundred and fifteen patients (13.74%) experienced chronic pain in the groin at 12-month follow-up, of whom 14 (2.67%) required analgesics. There were 6 patients with major morbidities and one patient died of an unrelated cause. Two hernia recurrences occurred within 12-month follow-up. Patients' QoL increased from an EQ-5D-3L index score of 0.82 ± 0.19 preoperatively to 0.90 ± 0.15 at 5 weeks (p < 0.0001) and 0.92 ± 0.15 at 12 months after surgery (p < 0.0001). The EQ-VAS general health scoring increased from 79.03 ± 12.69 preoperatively to 84.31 ± 9.97 at 5-week (p < 0.0001) and 84.16 ± 14.48 at 12-month follow-up (p < 0.0001).
Ifabond™ (Peters Surgical) is a safe, reliable, and feasible fixation method for laparoscopic inguinal hernia repair with a very high surgeon satisfaction score, improved patients' QoL, and comparable risk of developing chronic pain and postoperative complications as described in the literature.
腹股沟疝修补术是最常开展的外科手术之一。正在研究诸如手术胶水等穿透性补片固定术的替代方法，以评估其在减轻慢性疼痛方面的潜在益处。本研究的目的是评估正己基氰基丙烯酸酯胶水Ifabond™在腹腔镜腹股沟疝修补术中用于补片固定的疗效。
这项前瞻性、多中心、单臂研究收集了使用Ifabond™（法国布洛涅-比扬古赛德彼得斯外科公司）以及标准[Promesh® SURG ST（彼得斯外科公司）/Biomesh® P1（法国韦尔维克-叙德库辛生物技术公司）]或轻质[Promesh® SURG LI（彼得斯外科公司）/Premium® Implant（库辛生物技术公司）]聚丙烯补片进行腹腔镜腹股沟疝修补术的数据。主要终点是术后疼痛[100分制视觉模拟量表（VAS）]。次要终点是并发症、疝复发和生活质量（QoL）（EQ-5D-3L健康指数和EQ-VAS）。在术后5周和12个月对患者进行随访。
613例患者接受了腹腔镜腹股沟疝修补术。与术前（26.96±19.42）相比，术后5周（3.97±10.04；p<0.0001）和12个月（3.83±11.26；p<0.0001）随访时疼痛减轻。115例患者（13.74%）在12个月随访时腹股沟出现慢性疼痛，其中14例（2.67%）需要使用镇痛药。有6例患者发生严重并发症，1例患者死于无关原因。在12个月随访期间发生了2例疝复发。患者的生活质量从术前EQ-5D-3L指数评分0.82±0.19提高到术后5周的0.90±0.15（p<0.0001）和术后12个月的0.92±0.15（p<0.0001）。EQ-VAS总体健康评分从术前的79.03±12.69提高到术后5周的84.31±9.97（p<0.0001）和12个月随访时的84.16±14.48（p<0.0001）。
Ifabond™（彼得斯外科公司）是一种安全、可靠且可行的腹腔镜腹股沟疝修补术固定方法，外科医生满意度评分非常高，能改善患者生活质量，发生慢性疼痛和术后并发症的风险与文献中描述的相当。
