Nikkolo Ceith, Vaasna Tiit, Murruste Marko, Suumann Jaanus, Kirsimägi Ülle, Seepter Helmut, Tein Andres, Lepner Urmas
Surgery Clinic, Tartu University Hospital, Tartu 51014, Estonia.
Surgery Clinic, Tartu University Hospital, Tartu 51014, Estonia.
J Surg Res. 2017 Mar;209:139-144. doi: 10.1016/j.jss.2016.10.010. Epub 2016 Oct 15.
The primary aim of the present study was to evaluate whether usage of self-gripping mesh in open inguinal hernia repair, compared with standard Lichtenstein repair with sutured mesh, could result in a decreased rate of chronic pain. The secondary aim was to evaluate the rate of foreign body feeling, hernia recurrence, and risk factors for chronic pain development.
The patients were randomized into two study groups: the OLP group received Optilene LP mesh and the PPG group received self-gripping Parietex ProGrip mesh. Pain scores were measured on a visual analog scale. Foreign body feeling was registered as a yes-no question.
A total of 75 patients in the OLP group and 70 patients in the PPG group were analyzed at 3-y follow-up. According to the primary endpoint, of the patients, 41.3% in the OLP group and 28.6% in the PPG group experienced pain during different activities at 3-y follow-up (P = 0.108). The risk ratio for the primary endpoint was 1.45, 95% confidence interval (CI): 0.91, 2.29 (P = 0.114). Analysis demonstrated an increased rate of chronic pain in patients with severe preoperative pain (odds ratio: 2.47; 95% CI: 1.08, 5.65; P = 0.032) and severe early postoperative pain (odds ratio: 4.29; 95% CI: 1.82, 10.10; P = 0.001). Overall, of the patients, 28% in the OLP group and 21.4% in the PPG group reported foreign body feeling at the operation site at 3-y follow-up (P = 0.360). There were two hernia recurrences in the OLP group and none in the PPG group (P = 0.168).
We failed to demonstrate the advantages of self-gripping mesh in terms of chronic pain and foreign body feeling. However, usage of self-gripping mesh does not increase hernia recurrence rate. Considering the higher price of self-gripping mesh, analysis of cost-effectiveness is needed to prove its advantage and to justify its usage. As severe early postoperative pain is a risk factor for chronic pain development, a very effective postoperative pain control strategy is important after inguinal hernioplasty to reduce the rate of chronic pain.
本研究的主要目的是评估在开放性腹股沟疝修补术中使用自固定补片与采用缝合补片的标准Lichtenstein修补术相比,是否能降低慢性疼痛的发生率。次要目的是评估异物感发生率、疝复发率以及慢性疼痛发生的危险因素。
将患者随机分为两个研究组:OLP组接受Optilene LP补片,PPG组接受自固定Parietex ProGrip补片。采用视觉模拟量表测量疼痛评分。将异物感记录为是/否问题。
在3年随访时,对OLP组的75例患者和PPG组的70例患者进行了分析。根据主要终点指标,在3年随访时,OLP组41.3%的患者和PPG组28.6%的患者在不同活动时出现疼痛(P = 0.108)。主要终点指标的风险比为1.45,95%置信区间(CI):0.91,2.29(P = 0.114)。分析表明,术前疼痛严重的患者慢性疼痛发生率增加(比值比:2.47;95%CI:1.08,5.65;P = 0.032),术后早期疼痛严重的患者慢性疼痛发生率增加(比值比:4.29;95%CI:1.82,10.10;P = 0.001)。总体而言,在3年随访时,OLP组28%的患者和PPG组21.4%的患者报告手术部位有异物感(P = 0.360)。OLP组有2例疝复发,PPG组无复发(P = 0.168)。
我们未能证明自固定补片在慢性疼痛和异物感方面的优势。然而,使用自固定补片不会增加疝复发率。考虑到自固定补片价格较高,需要进行成本效益分析以证明其优势并证明其使用的合理性。由于术后早期疼痛严重是慢性疼痛发生的危险因素,腹股沟疝修补术后采用非常有效的术后疼痛控制策略对于降低慢性疼痛发生率很重要。