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CLINICAL TRIAL
JOURNAL ARTICLE
MULTICENTER STUDY
RANDOMIZED CONTROLLED TRIAL
RESEARCH SUPPORT, NON-U.S. GOV'T
Randomized clinical trial assessing impact of a lightweight or heavyweight mesh on chronic pain after inguinal hernia repair.
British Journal of Surgery 2005 Februrary
BACKGROUND: Severe chronic pain is a long-term problem that may occur after inguinal hernia repair. The aim of this randomized study was to compare pain of any severity at 12 months after inguinal hernia repair with a partially absorbable lightweight mesh (LW group) or with a non-absorbable heavyweight mesh (HW group).
METHODS: Patients were assessed for pain at 1, 3 and 12 months by questionnaire, and were examined clinically at 12 months.
RESULTS: Some 321 patients were included in an intention-to-treat analysis, 162 in the LW group and 159 in the HW group. At 12 months, significantly fewer patients in the LW group than in the HW group had pain of any severity: 39.5 versus 51.6 per cent (difference-12.1 (95 per cent confidence interval-23.1 to-1.0) per cent; P = 0.033). The recurrence rate was higher in the LW group (5.6 versus 0.4 per cent; P = 0.037). Five of eight recurrences in LW group were associated with a single participating centre.
CONCLUSION: Use of lightweight mesh was associated with less chronic pain but an increase in hernia recurrence after inguinal hernia repair. The latter may be related to technical factors associated with fixation of such meshes rather than any inherent defect in the mesh.
METHODS: Patients were assessed for pain at 1, 3 and 12 months by questionnaire, and were examined clinically at 12 months.
RESULTS: Some 321 patients were included in an intention-to-treat analysis, 162 in the LW group and 159 in the HW group. At 12 months, significantly fewer patients in the LW group than in the HW group had pain of any severity: 39.5 versus 51.6 per cent (difference-12.1 (95 per cent confidence interval-23.1 to-1.0) per cent; P = 0.033). The recurrence rate was higher in the LW group (5.6 versus 0.4 per cent; P = 0.037). Five of eight recurrences in LW group were associated with a single participating centre.
CONCLUSION: Use of lightweight mesh was associated with less chronic pain but an increase in hernia recurrence after inguinal hernia repair. The latter may be related to technical factors associated with fixation of such meshes rather than any inherent defect in the mesh.
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