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A randomized clinical trial comparing early patient-reported pain after open anterior mesh repair versus totally extraperitoneal repair of inguinal hernia
British Journal of Surgery ( IF 8.6 ) Pub Date : 2021-09-21 , DOI: 10.1093/bjs/znab354
Markku Matikainen 1 , Jaana Hellevi Vironen 2 , Seppo Silvasti 3 , Imre Ilves 4 , Jyrki Kössi 5 , Antti Kivivuori 1 , Hannu Paajanen 4
Affiliation  

Abstract Background This was a prospective, multicentre, non-blinded, randomized clinical trial involving two parallel groups of patients. Methods Adult patients with symptomatic unilateral primary inguinal hernia were included in this study. Patients were enrolled and treated in five Finnish hospitals. Eligible patients were randomized by use of a computer-based program to receiving either open anterior repair (modified Lichtenstein) with glue mesh fixation or totally extraperitoneal (TEP) repair. The primary aims were to compare 30-day patient-reported pain scores and return to work after surgery between the two groups. Results A total of 202 patients were randomized: 98 patients to TEP repair and 104 patients to open repair. All randomized patients received their allocated treatment. A total of 86 patients (88 per cent) in the TEP group and 94 patients (90 per cent) in the Lichtenstein group completed the 30-day follow-up. Patients experienced less early pain (P < 0.001) and used less analgesics after TEP repair, compared to those who had modified Lichtenstein repair. Two patients in the TEP group and five in the Lichtenstein group developed superficial wound infection (P = 0⋅446). Only one reoperation was performed in the Lichtenstein group due to haematoma. Conclusion TEP inguinal hernia repair is associated with less early postoperative pain compared to the open glue mesh fixation technique. Trial registration NCT03566433 (http://www.clinicaltrials.gov).

中文翻译:

一项随机临床试验,比较腹股沟疝开放性前网修复术后早期患者报告的疼痛与完全腹膜外修复术后的疼痛

摘要 背景这是一项前瞻性、多中心、非盲法、随机临床试验,涉及两组平行的患者。 方法本研究包括有症状的单侧原发性腹股沟疝的成年患者。患者在五家芬兰医院入组并接受治疗。通过使用基于计算机的程序,符合条件的患者被随机分配接受胶网固定的开放性前路修复(改良 Lichtenstein)或完全腹膜外(TEP)修复。主要目的是比较两组患者 30 天报告的疼痛评分以及手术后恢复工作的情况。 结果共有 202 名患者被随机分组​​:98 名患者接受 TEP 修复,104 名患者接受开放修复。所有随机分组的患者都接受了分配的治疗。TEP 组共有 86 名患者(88%)和 Lichtenstein 组有 94 名患者(90%)完成了 30 天的随访。与接受改良 Lichtenstein 修复的患者相比,TEP 修复后患者的早期疼痛较少(P < 0.001),并且使用的镇痛药也较少。TEP 组中有 2 名患者和 Lichtenstein 组有 5 名患者出现浅表伤口感染 (P = 0⋅446)。利希滕斯坦组仅因血肿进行了一次再次手术。 结论与开放式胶网固定技术相比,TEP 腹股沟疝修补术可减少术后早期疼痛。 试用注册NCT03566433 (http://www.clinicaltrials.gov)。
更新日期:2021-09-21
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