BACKGROUND: The Lichtenstein technique is the treatment of first choice according to guidelines for primary inguinal hernia treatment. Postoperative chronic pain has been reported as complication in 15-40 % after Lichtenstein's repair. The postoperative effects on health status after open preperitoneal hernia repair have hardly been examined. Development of an open technique that combines the safe anterior approach of the Lichtenstein with the 'promising' preperitoneal soft mesh position was done; the transinguinal preperitoneal (TIPP) mesh repair. A double-blind prospective randomized controlled trial (TULIP trial, ISRCTN93798494) was conducted to compare different outcome parameters after TIPP or Lichtenstein, one parameter is topic of evaluation in this paper; the health status after TIPP and Lichtensteinfor inguinal hernia repair. METHODS: The study protocol has been published. It was hypothesized that the health status of inguinal hernia patients would be better after the TIPP repair compared with the Lichtenstein technique. The size of this study was based on chronic pain as primary outcome measure. Three hundred and two patients were randomized. Patients and the outcome assessors were blinded. Follow-up was scheduled after 14 days, 3 months, and 1 year. The three dimensions of possible errors were warranted. RESULTS: With regard to health status, significant differences were found in the dimensions 'physical pain' [difference: 6.1 (95 % CI 2.3-9.9, p = 0.002)] and 'physical functioning' [difference: 3.5 (95 % CI 0.5-6.7, p = 0.023)], favoring the TIPP patients after 1 year. CONCLUSION: In conclusion, the SF-36 'physical function' and 'physical pain' dimensions after TIPP show significant better patient outcomes at 1 year compared with the Lichtenstein patients in this trial. These differences are in line with reported significant differences in less patients with postoperative chronic pain after TIPP compared with Lichtenstein at 1 year.
RCT Entities:
BACKGROUND: The Lichtenstein technique is the treatment of first choice according to guidelines for primary inguinal hernia treatment. Postoperative chronic pain has been reported as complication in 15-40 % after Lichtenstein's repair. The postoperative effects on health status after open preperitoneal hernia repair have hardly been examined. Development of an open technique that combines the safe anterior approach of the Lichtenstein with the 'promising' preperitoneal soft mesh position was done; the transinguinal preperitoneal (TIPP) mesh repair. A double-blind prospective randomized controlled trial (TULIP trial, ISRCTN93798494) was conducted to compare different outcome parameters after TIPP or Lichtenstein, one parameter is topic of evaluation in this paper; the health status after TIPP and Lichtenstein for inguinal hernia repair. METHODS: The study protocol has been published. It was hypothesized that the health status of inguinal herniapatients would be better after the TIPP repair compared with the Lichtenstein technique. The size of this study was based on chronic pain as primary outcome measure. Three hundred and two patients were randomized. Patients and the outcome assessors were blinded. Follow-up was scheduled after 14 days, 3 months, and 1 year. The three dimensions of possible errors were warranted. RESULTS: With regard to health status, significant differences were found in the dimensions 'physical pain' [difference: 6.1 (95 % CI 2.3-9.9, p = 0.002)] and 'physical functioning' [difference: 3.5 (95 % CI 0.5-6.7, p = 0.023)], favoring the TIPP patients after 1 year. CONCLUSION: In conclusion, the SF-36 'physical function' and 'physical pain' dimensions after TIPP show significant better patient outcomes at 1 year compared with the Lichtenstein patients in this trial. These differences are in line with reported significant differences in less patients with postoperative chronic pain after TIPP compared with Lichtenstein at 1 year.
Authors: Frederik Keus; Jørn Wetterslev; Christian Gluud; Hein G Gooszen; Cornelis J H M van Laarhoven Journal: J Clin Epidemiol Date: 2009-12-11 Impact factor: 6.437
Authors: N K Aaronson; M Muller; P D Cohen; M L Essink-Bot; M Fekkes; R Sanderman; M A Sprangers; A te Velde; E Verrips Journal: J Clin Epidemiol Date: 1998-11 Impact factor: 6.437
Authors: M Miserez; J H Alexandre; G Campanelli; F Corcione; D Cuccurullo; M Hidalgo Pascual; A Hoeferlin; A N Kingsnorth; V Mandala; J P Palot; V Schumpelick; R K J Simmermacher; R Stoppa; J B Flament Journal: Hernia Date: 2007-03-13 Impact factor: 4.739
Authors: Frederik Keus; Jørn Wetterslev; Christian Gluud; Cornelis J H M van Laarhoven Journal: BMC Med Res Methodol Date: 2010-10-01 Impact factor: 4.615
Authors: G G Koning; F Keus; L Koeslag; C L Cheung; M Avçi; C J H M van Laarhoven; P W H E Vriens Journal: Br J Surg Date: 2012-10 Impact factor: 6.939
Authors: W J V Bökkerink; G G Koning; D Malagic; L van Hout; C J H M van Laarhoven; P W H E Vriens Journal: Br J Surg Date: 2019-04-17 Impact factor: 6.939