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JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL
Long-term results of a prospective randomized trial of midline laparotomy closure with onlay mesh.
PURPOSE: Incisional hernia (IH) continues to be one of the most common complications of laparotomy. The short-term protective effect of the use of mesh has been demonstrated in several studies. At present, there is little evidence on the long-term results of the prophylactic use of mesh. The aim of the present study is to analyze the long-term prevention of IH 5 years after a midline laparotomy during elective surgery.
METHODS: A prospective study was performed including all of the 160 patients that had been previously included in the prospective, randomized, controlled trial performed between May 2009 and November 2012. The protocol and results at 1 year have been previously published in 2014. The patients in group A (mesh) were fitted with a polypropylene mesh to reinforce the standard abdominal wall closure. The patients in group B (non-mesh) underwent a standard abdominal wall closure and were not fitted with the mesh. All patients were followed for 5 years or until the diagnosis of incisional hernia was made, further surgery was performed, or the patient died. Cases lost to follow-up were also registered.
RESULTS: Five years after surgery, in group A (mesh) we have found 4/80 (5.1%) incisional hernias, while in group B (no mesh) 37/80 patients were diagnosed with an incisional hernia (46.8%). The Kaplan-Meier survival curves for these results show statistically significant differences (p > 0.001).
CONCLUSION: The protective effect of the use of an onlay mesh in abdominal wall closure is significantly maintained in the long-term, up to 5 years after surgery. International Standard Randomized Controlled Trial number: ISRCTN98336745.
METHODS: A prospective study was performed including all of the 160 patients that had been previously included in the prospective, randomized, controlled trial performed between May 2009 and November 2012. The protocol and results at 1 year have been previously published in 2014. The patients in group A (mesh) were fitted with a polypropylene mesh to reinforce the standard abdominal wall closure. The patients in group B (non-mesh) underwent a standard abdominal wall closure and were not fitted with the mesh. All patients were followed for 5 years or until the diagnosis of incisional hernia was made, further surgery was performed, or the patient died. Cases lost to follow-up were also registered.
RESULTS: Five years after surgery, in group A (mesh) we have found 4/80 (5.1%) incisional hernias, while in group B (no mesh) 37/80 patients were diagnosed with an incisional hernia (46.8%). The Kaplan-Meier survival curves for these results show statistically significant differences (p > 0.001).
CONCLUSION: The protective effect of the use of an onlay mesh in abdominal wall closure is significantly maintained in the long-term, up to 5 years after surgery. International Standard Randomized Controlled Trial number: ISRCTN98336745.
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