Three-year results of a randomized study comparing self-gripping mesh with sutured mesh in open inguinal hernia repair.

BACKGROUND: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.

Single-center, single-blinded, randomized study of self-gripping versus sutured mesh in open inguinal hernia repair.

BACKGROUND: 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 at 6-mo follow-up. The secondary outcome was to evaluate foreign body feeling and the quality of life after inguinal hernia repair. METHODS: The patients were randomized into two study groups as follows: 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 or no question. Quality of life was evaluated using the Medical Outcome Study Short-Form 36 questionnaire. RESULTS: A total of 75 patients in the OLP group and 70 patients in the PPG group were included in the analysis. According to the primary end point, 45.3% and 31.4% of the patients in the OLP group and PPG group experienced pain during different activities at 6-mo follow-up, respectively (P = 0.092). Per secondary end point, 22.7% in the OLP group and 40% in the PPG group reported foreign body feeling at the operation site at 6-mo follow-up (P = 0.031, risk ratio 0.57, 95% confidence interval 0.29-1.07). There were no significant differences in any domain of quality of life according to the Short-Form 36 questionnaire between the two study groups at 6-mo follow-up, except for the social functioning domain (P = 0.035). In the OLP group, the quality of life scores improved significantly after operation in all domains except for general health and mental health. In the PPG group, the quality of life scores improved significantly after operation in the domains of bodily pain, physical functioning, and physical role. CONCLUSIONS: Self-gripping mesh compared with standard Lichtenstein operation has no advantages in reducing chronic pain 6-mo after surgery. The rate of foreign body feeling was higher in the self-gripping mesh group. Scores of bodily pain, physical functioning, and physical role improved significantly in both study groups after hernia surgery.

Randomized clinical study evaluating the impact of mesh pore size on chronic pain after Lichtenstein hernioplasty.

BACKGROUND: The primary aim of this study was to determine whether mesh pore size influences the rate of chronic pain at 6-mo follow-up. Another aim was to evaluate the rate of foreign body feeling and quality of life after inguinal hernia repair. METHODS: The patients were randomized into two study groups: the UM group received Ultrapro mesh (pore size 3-4 mm) and the OM group received Optilene LP mesh (pore size 1 mm). Pain scores were measured on a visual analog scale. The feeling of a foreign body was a yes-or-no question. Quality of life was evaluated using the Medical Outcome Study Short-Form-36 questionnaire. RESULTS: A total of 67 patients in the UM group and 67 patients in the OM group were investigated 6 mo after operation. There were no significant differences in the results of the pain questionnaire between the study groups. Of the patients, 46.3% in the UM group reported pain during different activities at 6-mo follow-up versus 34.3% in the OM group (P = 0.165). The feeling of a foreign body in the inguinal region was experienced by 47.8% of the patients in the UM group and by 31.3% of the patients in the OM group at 6-mo follow-up (P = 0.052; risk ratio 1.52, 95% confidence interval: 1.00-2.37). There were no significant differences in the quality of life according to the Short-Form 36 questionnaire between the two study groups at 6-mo follow-up. In both study groups, the quality of life scores improved after operation by most dimensions. CONCLUSIONS: Differences in mesh pore size did not influence the rate of chronic pain. Although there was a trend for higher rate of foreign body feeling in the study group where a mesh with larger pores was used, we failed to find an explanation for this. The pore size of meshes investigated in this study did not affect the quality of life after inguinal hernia repair. Considering the fact that the quality of life improved significantly after operation, elective repair of symptomatic inguinal hernias should be undertaken as promptly as possible.

Safety and efficacy of tigecycline in treatment of skin and skin structure infections: results of a double-blind phase 3 comparison study with vancomycin-aztreonam.

In a randomized, double-blind, controlled trial, 546 patients with complicated skin and skin structure infections received tigecycline 100 mg/day (a 100-mg initial dose and then 50 mg intravenously twice daily) or the combination of vancomycin 2 g/day (1 g intravenously twice daily) and aztreonam 4 g/day (2 g intravenously twice daily) for up to 14 days. The primary end point was the clinical response in the clinical modified intent-to-treat (c-mITT) and clinically evaluable (CE) populations at the test-of-cure visit 12 to 92 days after the last dose. The microbiologic response at the test-of-cure visit was also assessed. Safety was assessed by physical examination, laboratory results, and adverse event reporting. Five hundred twenty patients were included in the c-mITT population (tigecycline group, n = 261; combination group, n = 259), and 436 were clinically evaluable (tigecycline group, n = 223; combination group, n = 213). The clinical responses in the tigecycline and the combination vancomycin and aztreonam groups were similar in the c-mITT population (84.3% versus 86.9%; difference, -2.6% [95% confidence interval, -9.0, 3.8]; P = 0.4755) and the CE population (89.7% versus 94.4%; difference, -4.7% [95% confidence interval, -10.2, 0.8]; P = 0.1015). Microbiologic eradication (documented or presumed) occurred in 84.8% of the patients receiving tigecycline and 93.2% of the patients receiving vancomycin and aztreonam (difference, -8.5 [95% confidence interval, -16.0, -1.0]; P = 0.0243). The numbers of patients reporting adverse events were similar in the two groups, with increased nausea and vomiting rates in the tigecycline group and an increased incidence of rash and increases in alanine aminotransferase and aspartate aminotransferase levels in the combination vancomycin and aztreonam group. Tigecycline was shown to be safe and effective for the treatment of complicated skin and skin structure infections.