Rutegård M, Gümüsçü R, Stylianidis G, Nordin P, Nilsson E, Haapamäki M M
Department of Surgery and Perioperative Sciences, Surgery, Umeå University, 901 85, Umeå, Sweden.
Hernia. 2018 Jun;22(3):411-418. doi: 10.1007/s10029-018-1734-z. Epub 2018 Jan 20.
There is a paucity of high-quality evidence concerning mesh choice in open inguinal hernia repair. Using an expertise-based randomized clinical trial design, we aimed to evaluate the postoperative impact of two different mesh types on pain and discomfort, quality of life and sex life.
In two regional hospitals, male patients with primary inguinal hernia were randomized to one of two groups of surgeons that performed the Lichtenstein operation. One group of surgeons used a heavyweight polypropylene mesh (90 g/m, Bard™ Flatmesh, Davol) while the second group employed a lightweight mesh (28 g/m, ULTRAPRO™, Ethicon). Follow-up data were collected by questionnaires and outpatient visits in the range of 1-3 years after surgery.
Some 412 patients were randomized and 363 patients were analysed. There was no difference in pain between groups after surgery but a statistically significant difference concerning awareness of a groin lump and groin discomfort, favouring the lightweight group 1 year after surgery. No differences in quality of life between groups could be detected but both groups had a substantially better quality of life postoperatively, as compared to before surgery. In the analysis of impact on sex life, no differences between mesh groups were found.
The Lichtenstein operation performed for primary inguinal hernia improves quality of life for most of the male patients, independently of the type of mesh used. The lightweight mesh group experienced less awareness of a groin lump and groin discomfort 1 year postoperatively. ClinicalTrials.gov Identifier: NCT00451893.
关于开放式腹股沟疝修补术中补片选择的高质量证据匮乏。我们采用基于专业知识的随机临床试验设计,旨在评估两种不同补片类型对疼痛与不适、生活质量及性生活的术后影响。
在两家地区医院,将原发性腹股沟疝男性患者随机分配至两组外科医生之一,由其实施Lichtenstein手术。一组外科医生使用重磅聚丙烯补片(90 g/m²,Bard™ Flatmesh,Davol),另一组使用轻量补片(28 g/m²,ULTRAPRO™,Ethicon)。术后1至3年通过问卷调查和门诊随访收集随访数据。
约412例患者被随机分组,363例患者接受分析。术后两组疼痛无差异,但术后1年,在腹股沟肿块感知和腹股沟不适方面存在统计学显著差异,轻量补片组更具优势。两组生活质量无差异,但与术前相比,两组术后生活质量均显著改善。在对性生活影响的分析中,补片组间未发现差异。
原发性腹股沟疝的Lichtenstein手术可改善大多数男性患者的生活质量,与所用补片类型无关。轻量补片组术后1年对腹股沟肿块和腹股沟不适的感知较少。ClinicalTrials.gov标识符:NCT00451893。