PURPOSE: We investigated whether new absorbable materials can be used in the treatment of inguinal hernia with the same efficacy as the traditionally used polypropylene. METHODS: We compared local tissue inflammation and fibrous reaction, postoperative complications (bleeding, wound haematoma, wound infection) and postoperative recovery time (time of mobilisation) in rats (Fischer strain) after implantation of a polypropylene mesh (PPM) (Prolene, Ethicon, Bracknell, UK) or a dual component fibrin mesh (DCFM) (Tachosil, Nycomed, Marlow, UK), between the muscle layer and the fascia transversalis defect. We further compared direct hernia repair methods using Lichtenstein's operation in humans after implantation of either PPM or DCFM for fascia transversalis reinforcement regarding postoperative pain and complications, time needed for patient mobilisation, and recurrence. RESULTS: The results show that implantation of DCFM in rats resulted in milder inflammatory response and thicker fibrous tissue formation. Patients implanted with DCFM had significantly lower postoperative pain scores on a visual-analogue scale and lower analgesic use. The overall incidence of postoperative complications was significantly reduced with the use of DCFM. The incidence of recurrence after 24-month follow-up was the same in both groups. CONCLUSION: This study has shown that DCFM has the same short-term efficacy in hernia treatment as the standard PPM, with a reduction in postoperative pain and analgesic use, and a decrease in overall postoperative complications. In the rat model, DCFM resulted in milder inflammatory response and thicker fibrous plate than the PPM. Further biomechanical testing and longer follow-up is necessary, but initial results are promising.
RCT Entities:
PURPOSE: We investigated whether new absorbable materials can be used in the treatment of inguinal hernia with the same efficacy as the traditionally used polypropylene. METHODS: We compared local tissue inflammation and fibrous reaction, postoperative complications (bleeding, wound haematoma, wound infection) and postoperative recovery time (time of mobilisation) in rats (Fischer strain) after implantation of a polypropylene mesh (PPM) (Prolene, Ethicon, Bracknell, UK) or a dual component fibrin mesh (DCFM) (Tachosil, Nycomed, Marlow, UK), between the muscle layer and the fascia transversalis defect. We further compared direct hernia repair methods using Lichtenstein's operation in humans after implantation of either PPM or DCFM for fascia transversalis reinforcement regarding postoperative pain and complications, time needed for patient mobilisation, and recurrence. RESULTS: The results show that implantation of DCFM in rats resulted in milder inflammatory response and thicker fibrous tissue formation. Patients implanted with DCFM had significantly lower postoperative pain scores on a visual-analogue scale and lower analgesic use. The overall incidence of postoperative complications was significantly reduced with the use of DCFM. The incidence of recurrence after 24-month follow-up was the same in both groups. CONCLUSION: This study has shown that DCFM has the same short-term efficacy in hernia treatment as the standard PPM, with a reduction in postoperative pain and analgesic use, and a decrease in overall postoperative complications. In the rat model, DCFM resulted in milder inflammatory response and thicker fibrous plate than the PPM. Further biomechanical testing and longer follow-up is necessary, but initial results are promising.
Authors: David Shin; Larry I Lipshultz; Marc Goldstein; Gregory A Barmé; Eugene F Fuchs; Harris M Nagler; Stewart W McCallum; Craig S Niederberger; Richard A Schoor; Victor M Brugh; Stanton C Honig Journal: Ann Surg Date: 2005-04 Impact factor: 12.969