G Champault1, A Torcivia, L Paolino, W Chaddad, F Lacaine, C Barrat. 1. Service de Chirurgie Digestive Pr G Champault-Pr C Barrat, CHU J. Verdier, France Université Paris XIII, Av du 14 Juillet, 93140 Bondy, France. gerardchampault1@aol.com
Abstract
BACKGROUND: Prosthetic reinforcement is the gold standard treatment for inguinal hernia and reduces the risk of recurrence. Yet up to one-third of patients complain of post-surgical pain due to irritation and inflammation caused by the mesh and the fixation materials. Of these patients, 3-4% will experience severe and disabling chronic pain. We performed a prospective multicenter clinical study of a self-adhering prosthesis, consisting of a lightweight polypropylene mesh (40 g/m²) coated on each side with synthetic glue, to evaluate early postoperative complications and patient outcomes. PATIENTS AND METHODS: Between August 2008 and June 2010, 186 patients underwent hernia repair using the Lichtenstein technique and the self-adhering prosthesis. Primary endpoints were the frequency of disabling complications and quality of life (QoL) at 3-month follow-up. Pain, numbness, and groin discomfort were evaluated pre- and postoperatively (1 week, 1 and 3 months) using a visual analogue scale (VAS). Patients' pre- and postoperative QoL were measured using the SF12 questionnaire. Secondary endpoints were number of complications and recurrence rate, use of analgesic drugs, length of hospital stay, delay to return to normal activities, and patient satisfaction. The quality of the self-adhering mesh and its clinical utility were also evaluated by the participating surgeons. RESULTS: A total of 186 patients were enrolled and followed for at least 3 months after inguinal hernia repair. A total of 174 (95%) primary hernias and 12 (5%) recurrent hernias were treated. There were no intraoperative complications, no recurrences, and no repeat interventions performed during the study. The post-surgical complication rate was 4.5%. The mean delay to recover normal physical activity was 4 days. For the primary endpoint of pain, a VAS of zero was reported by 93/184 (50.5%) patients at 1 week, 130/171 (76.0%) patients at 1 month and 119/132 (90.2%) patients at 3 months' follow-up (P < 0.0001). The postoperative SF12 scores showed a significant improvement in patient QoL following surgery (P < 0.0001). CONCLUSIONS: Adhesix( ® ) self-adhering mesh for prosthetic reinforcement following inguinal hernia repair is atraumatic and associated with infrequent post-surgical complications or pain, a rapid recovery rate, and a high patient-reported QoL. A longer follow-up is underway to assess the frequency of post-surgical recurrence.
BACKGROUND: Prosthetic reinforcement is the gold standard treatment for inguinal hernia and reduces the risk of recurrence. Yet up to one-third of patients complain of post-surgical pain due to irritation and inflammation caused by the mesh and the fixation materials. Of these patients, 3-4% will experience severe and disabling chronic pain. We performed a prospective multicenter clinical study of a self-adhering prosthesis, consisting of a lightweight polypropylene mesh (40 g/m²) coated on each side with synthetic glue, to evaluate early postoperative complications and patient outcomes. PATIENTS AND METHODS: Between August 2008 and June 2010, 186 patients underwent hernia repair using the Lichtenstein technique and the self-adhering prosthesis. Primary endpoints were the frequency of disabling complications and quality of life (QoL) at 3-month follow-up. Pain, numbness, and groin discomfort were evaluated pre- and postoperatively (1 week, 1 and 3 months) using a visual analogue scale (VAS). Patients' pre- and postoperative QoL were measured using the SF12 questionnaire. Secondary endpoints were number of complications and recurrence rate, use of analgesic drugs, length of hospital stay, delay to return to normal activities, and patient satisfaction. The quality of the self-adhering mesh and its clinical utility were also evaluated by the participating surgeons. RESULTS: A total of 186 patients were enrolled and followed for at least 3 months after inguinal hernia repair. A total of 174 (95%) primary hernias and 12 (5%) recurrent hernias were treated. There were no intraoperative complications, no recurrences, and no repeat interventions performed during the study. The post-surgical complication rate was 4.5%. The mean delay to recover normal physical activity was 4 days. For the primary endpoint of pain, a VAS of zero was reported by 93/184 (50.5%) patients at 1 week, 130/171 (76.0%) patients at 1 month and 119/132 (90.2%) patients at 3 months' follow-up (P < 0.0001). The postoperative SF12 scores showed a significant improvement in patient QoL following surgery (P < 0.0001). CONCLUSIONS: Adhesix( ® ) self-adhering mesh for prosthetic reinforcement following inguinal hernia repair is atraumatic and associated with infrequent post-surgical complications or pain, a rapid recovery rate, and a high patient-reported QoL. A longer follow-up is underway to assess the frequency of post-surgical recurrence.
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