BACKGROUND: Refinements in the configuration of mesh may ease handling and placement and reduce postoperative discomfort. MATERIAL AND METHODS: A total of 206 patients were randomly and blindly allocated to receive the Prolene Hernia System (PHS) or Lichtenstein patch. Collected data included: surgical incision size, procedure time, pain scores, analgesic medication, complications, return to activity and work, and quality of life as measured by Short-Form 36 on days 3 and 14. RESULTS:Immediate post-operative pain was significantly lower with PHS than with the patch. The proportion of PHS patients taking longer than 3 days to return to normal activity was 15.5%, compared to 28.4% of patch patients. Operating time was significantly shorter with PHS (34.1 vs. 38.3 min). There was no treatment effect on any of the quality of life scales as measured by Short-Form 36. There were two recurrences in the patch group. CONCLUSIONS: The study indicates a reduction in operating time (4 min) and postoperative recovery with the PHS compared with patch.
RCT Entities:
BACKGROUND: Refinements in the configuration of mesh may ease handling and placement and reduce postoperative discomfort. MATERIAL AND METHODS: A total of 206 patients were randomly and blindly allocated to receive the Prolene Hernia System (PHS) or Lichtenstein patch. Collected data included: surgical incision size, procedure time, pain scores, analgesic medication, complications, return to activity and work, and quality of life as measured by Short-Form 36 on days 3 and 14. RESULTS: Immediate post-operative pain was significantly lower with PHS than with the patch. The proportion of PHS patients taking longer than 3 days to return to normal activity was 15.5%, compared to 28.4% of patch patients. Operating time was significantly shorter with PHS (34.1 vs. 38.3 min). There was no treatment effect on any of the quality of life scales as measured by Short-Form 36. There were two recurrences in the patch group. CONCLUSIONS: The study indicates a reduction in operating time (4 min) and postoperative recovery with the PHS compared with patch.
Authors: M P Simons; T Aufenacker; M Bay-Nielsen; J L Bouillot; G Campanelli; J Conze; D de Lange; R Fortelny; T Heikkinen; A Kingsnorth; J Kukleta; S Morales-Conde; P Nordin; V Schumpelick; S Smedberg; M Smietanski; G Weber; M Miserez Journal: Hernia Date: 2009-07-28 Impact factor: 4.739