György Wéber1, József Baracs, Ors Péter Horváth. 1. Pécsi Tudományegyetem, Általános Orvostudományi Kar Sebészeti Klinika 7624 Pécs Kodály Z. u. 20. Pécsi Tudományegyetem, Általános Orvostudományi Kar Sebészeti Oktató és Kutató Intézet Pécs. gyorgy.weber@aok.pte.hu
Abstract
BACKGROUND: There are several well-known procedures to treat abdominal wall hernias, but the results are quite controversial. The aim of study was to compare the results of different surgical modalities - mesh (onlay vs. sublay position) and suture repair - in the treatment of abdominal wall hernias. METHODS: A five-year randomized, multicentric, internet-based, clinical trial was started in 2002. 953 patients were included in the study and divided into two groups according to the size of hernia orifice. In group 'A' ( n = 494) the surface of hernia orifice was between 5-25 cm 2 (small hernia), and in group 'B' ( n = 459) it was above 25 cm 2 (large hernia). Patients of these two groups were randomized according to surgery: group 'A' (suture vs. mesh) and in group 'B' (mesh in onlay vs. sublay position). In group 'A' suture repair was performed in 247, and sublay mesh implantation in 247 cases. In group 'B' sublay ( n = 235) and onlay ( n = 224) mesh reconstruction was performed. The patients were followed-up for five years. RESULTS:734 patients - 77% of all randomized cases - have completed the study. In the small hernia group significantly ( p < 0.001) higher recurrences occurred after suture repair ( n = 50-27%) than in mesh repair ( n = 15-8%). In the large hernia group onlay mesh reconstruction provided significantly better ( p < 0.05) results than sublay reconstruction, recurrence rate was much lower in onlay group [ n = 22 (12%) vs. n = 38 (20%)]. CONCLUSION:Mesh repair provides better results than suture repair. In case of large hernias the recurrence rate is higher after sublay reconstruction. The randomized trial was registered on <a href="http://www.ClinicalTrials.gov">www.ClinicalTrials.gov</a> - ID number: NCT01018524.
RCT Entities:
BACKGROUND: There are several well-known procedures to treat abdominal wall hernias, but the results are quite controversial. The aim of study was to compare the results of different surgical modalities - mesh (onlay vs. sublay position) and suture repair - in the treatment of abdominal wall hernias. METHODS: A five-year randomized, multicentric, internet-based, clinical trial was started in 2002. 953 patients were included in the study and divided into two groups according to the size of hernia orifice. In group 'A' ( n = 494) the surface of hernia orifice was between 5-25 cm 2 (small hernia), and in group 'B' ( n = 459) it was above 25 cm 2 (large hernia). Patients of these two groups were randomized according to surgery: group 'A' (suture vs. mesh) and in group 'B' (mesh in onlay vs. sublay position). In group 'A' suture repair was performed in 247, and sublay mesh implantation in 247 cases. In group 'B' sublay ( n = 235) and onlay ( n = 224) mesh reconstruction was performed. The patients were followed-up for five years. RESULTS: 734 patients - 77% of all randomized cases - have completed the study. In the small hernia group significantly ( p < 0.001) higher recurrences occurred after suture repair ( n = 50-27%) than in mesh repair ( n = 15-8%). In the large hernia group onlay mesh reconstruction provided significantly better ( p < 0.05) results than sublay reconstruction, recurrence rate was much lower in onlay group [ n = 22 (12%) vs. n = 38 (20%)]. CONCLUSION: Mesh repair provides better results than suture repair. In case of large hernias the recurrence rate is higher after sublay reconstruction. The randomized trial was registered on <a href="http://www.ClinicalTrials.gov">www.ClinicalTrials.gov</a> - ID number: NCT01018524.
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