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Randomized Controlled Trial Multicenter Study
A randomized clinical trial comparing early patient-reported pain after open anterior mesh repair versus totally extraperitoneal repair of inguinal hernia.
- Markku Matikainen, Jaana Hellevi Vironen, Seppo Silvasti, Imre Ilves, Jyrki Kössi, Antti Kivivuori, and Hannu Paajanen.
- Department of Gastrointestinal Surgery, Kuopion Yliopistollinen Sairaala, Kuopio, Finland.
- Br J Surg. 2021 Dec 1; 108 (12): 143314371433-1437.
BackgroundThis was a prospective, multicentre, non-blinded, randomized clinical trial involving two parallel groups of patients.MethodsAdult 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.ResultsA 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.ConclusionTEP inguinal hernia repair is associated with less early postoperative pain compared to the open glue mesh fixation technique.Trial RegistrationNCT03566433 (http://www.clinicaltrials.gov).© The Author(s) 2021. Published by Oxford University Press on behalf of BJS Society Ltd. All rights reserved. For permissions, please email: journals.permissions@oup.com.
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