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Randomized Controlled Trial Comparative Study
Three-year results of a randomized study comparing self-gripping mesh with sutured mesh in open inguinal hernia repair.
- Ceith Nikkolo, Tiit Vaasna, Marko Murruste, Jaanus Suumann, Ülle Kirsimägi, Helmut Seepter, Andres Tein, and Urmas Lepner.
- Surgery Clinic, Tartu University Hospital, Tartu 51014, Estonia.
- J. Surg. Res. 2017 Mar 1; 209: 139-144.
BackgroundThe 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.MethodsThe 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.ResultsA 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).ConclusionsWe 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.Copyright © 2016 Elsevier Inc. All rights reserved.
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