Matikainen Markku, Vironen Jaana Hellevi, Silvasti Seppo, Ilves Imre, Kössi Jyrki, Kivivuori Antti, Paajanen Hannu
Department of Gastrointestinal Surgery, Kuopion Yliopistollinen Sairaala, Kuopio, Finland.
Department of Gastrointestinal Surgery, Helsinki University Central Hospital, Espoo, Finland.
Br J Surg. 2021 Dec 1;108(12):1433-1437. doi: 10.1093/bjs/znab354.
This was a prospective, multicentre, non-blinded, randomized clinical trial involving two parallel groups of patients.
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.
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.
TEP inguinal hernia repair is associated with less early postoperative pain compared to the open glue mesh fixation technique.
NCT03566433 (http://www.clinicaltrials.gov).
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。
本研究纳入有症状的单侧原发性腹股沟疝成年患者。患者在芬兰的五家医院入组并接受治疗。符合条件的患者通过计算机程序随机分为接受开放式前路修补术（改良Lichtenstein术）加胶水网片固定或完全腹膜外（TEP）修补术。主要目的是比较两组患者术后30天的患者报告疼痛评分和术后恢复工作情况。
共有202例患者被随机分组：98例接受TEP修补术，104例接受开放式修补术。所有随机分组的患者均接受了分配的治疗。TEP组共有86例患者（88%）和Lichtenstein组94例患者（90%）完成了30天随访。与接受改良Lichtenstein修补术的患者相比，TEP修补术后患者早期疼痛较轻（P<0.001）且使用的镇痛药较少。TEP组有2例患者和Lichtenstein组有5例患者发生浅表伤口感染（P=0.446）。Lichtenstein组仅因血肿进行了1次再次手术。
与开放式胶水网片固定技术相比，TEP腹股沟疝修补术术后早期疼痛较轻。
NCT03566433（http://www.clinicaltrials.gov）。
