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.
RCT Entities:
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.
Authors: Merritt Denham; Brandon Johnson; Michelle Leong; Kristine Kuchta; Eliza Conaty; Michael B Ujiki; Woody Denham; Stephen P Haggerty; Zeeshan Butt; JoAnn Carbray; Matt Gitelis; John G Linn Journal: Surg Endosc Date: 2019-01-09 Impact factor: 4.584
Authors: S van Steensel; L K van Vugt; A K Al Omar; E H H Mommers; S O Breukink; L P S Stassen; B Winkens; N D Bouvy Journal: BJS Open Date: 2019-02-27