Wen Wen, Majerus Bernard, Van De Moortel Marijke, Lobue Salvatore, Fobe Didier, Philippart Patrick, Berwouts Luc, Coteur Joris, Gabriels Karen, Van der Speeten Kurt
a Hospital East Limburg , Genk , Belgium.
b Hospital Saint-Pierre , Ottignies , Belgium.
Acta Chir Belg. 2017 Oct;117(5):295-302. doi: 10.1080/00015458.2017.1313526. Epub 2017 Apr 25.
Abdominal wall hernias are a common problem. Composite meshes placed intraperitoneally for abdominal wall hernia repair are widely used. This registry evaluated the safety and efficacy of one specific composite mesh with polypropylene and expanded polytetrafluoroethylene (Intramesh T1) in laparoscopic ventral hernia repair.
A prospective multicentre registry with data from seven centres was collected between January 2013 and September 2014. Primary endpoint was recurrence rate at 12 months determined by clinical examination. Secondary outcome measures included intraoperative complications, complications during hospitalisation and at 1-month and 12-months follow-up.
The registry included 90 patients (30 female and 60 male). Fifty-five patients (61.1%) presented with primary ventral hernias and 35 patients (38.9%) with incisional ventral hernias. Median hernia size was 4 cm. Intraoperative complications were reported in two patients (2.2%). Complications during hospitalisation were reported in four (4.4%) patients. At 1-month follow-up, 17 (18.9%) patients had postoperative complications, of which 5 complications were major and 19 were minor. Late complications at 12-months were observed in 10 patients (11.1%), of which 2 were major and 8 minor complications.
Intramesh T1 is a safe and effective composite mesh with favourable short and midterm outcome and morbidity. (NCT01816867).
腹壁疝是一个常见问题。用于腹壁疝修补的腹腔内放置的复合补片被广泛使用。本注册研究评估了一种特定的聚丙烯和膨化聚四氟乙烯复合补片(Intramesh T1)在腹腔镜腹疝修补中的安全性和有效性。
收集了2013年1月至2014年9月间来自7个中心的前瞻性多中心注册研究数据。主要终点是通过临床检查确定的12个月时的复发率。次要观察指标包括术中并发症、住院期间及1个月和12个月随访时的并发症。
该注册研究纳入了90例患者(30例女性和60例男性)。55例患者(61.1%)为原发性腹疝,35例患者(38.9%)为切口疝。疝的中位大小为4厘米。2例患者(2.2%)报告有术中并发症。4例(4.4%)患者报告有住院期间并发症。在1个月随访时,17例(18.9%)患者有术后并发症,其中5例为严重并发症,19例为轻微并发症。12个月时观察到10例患者(11.1%)有晚期并发症,其中2例为严重并发症,8例为轻微并发症。
Intramesh T1是一种安全有效的复合补片,具有良好的短期和中期疗效及发病率。(NCT01816867)