BACKGROUND:Groin hernia repair is one of the commonest operations in general surgery. Existing techniques have very low and acceptable recurrence rates, but chronic pain and discomfort remain a problem for many patients. New mesh materials are being developed to increase biocompatibility, and the aim of this study was to compare a new titanium-coated lightweight mesh with a standard polypropylene mesh. METHODS: A randomized controlled single-centre clinical trial was designed, with the basic principle of one unit, one surgeon, one technique (Lichtenstein under general anaesthesia) and two meshes. Pain before and after surgery, and during convalescence (primary outcomes) was estimated in 317 patients. At 1-year clinical follow-up, recurrence, pain, discomfort and quality of life (secondary outcomes) were evaluated. RESULTS: Patients with the lightweight mesh returned to work after 4 days, compared with 6.5 days for the standard mesh (P = 0.040). The lightweight group returned to normal activity after 7 days, versus 10 days for the standard group (P = 0.005). There was no difference in postoperative pain or recurrence at the 1-year follow-up. CONCLUSION: Patients with the lightweight mesh had a shorter convalescence than those with the standard heavyweight mesh. REGISTRATION NUMBER: ISRCTN36979348 (http://www.controlled-trials.com).
RCT Entities:
BACKGROUND: Groin hernia repair is one of the commonest operations in general surgery. Existing techniques have very low and acceptable recurrence rates, but chronic pain and discomfort remain a problem for many patients. New mesh materials are being developed to increase biocompatibility, and the aim of this study was to compare a new titanium-coated lightweight mesh with a standard polypropylene mesh. METHODS: A randomized controlled single-centre clinical trial was designed, with the basic principle of one unit, one surgeon, one technique (Lichtenstein under general anaesthesia) and two meshes. Pain before and after surgery, and during convalescence (primary outcomes) was estimated in 317 patients. At 1-year clinical follow-up, recurrence, pain, discomfort and quality of life (secondary outcomes) were evaluated. RESULTS:Patients with the lightweight mesh returned to work after 4 days, compared with 6.5 days for the standard mesh (P = 0.040). The lightweight group returned to normal activity after 7 days, versus 10 days for the standard group (P = 0.005). There was no difference in postoperative pain or recurrence at the 1-year follow-up. CONCLUSION:Patients with the lightweight mesh had a shorter convalescence than those with the standard heavyweight mesh. REGISTRATION NUMBER: ISRCTN36979348 (http://www.controlled-trials.com).