Contributions of the Registers in Complement to the RCT About Hernia Club Registries

The Randomized Controlled Trial (RCT) is the best tool in comparing two treatments, especially two drug therapies;In the other hand, the RCT encompasses some limitations, especially when comparing surgical techniques or prostheses.The randomization does not preclude some occult bias, related to the learning curve, the unachievable double blind, the heterogeneousness of these diseases, …The RCT require a lot of time and money. Their results concern only the restricted (inclusion /exclusion) studied population and are not easily transposable in the ‘real world’. Finally the RCT are delimited in time and shape and therefore not able to detect late or rare events.Conversely, in the registers, the procedure is done by a surgeon used to his favourite technique. A lot of different techniques and meshes can be simultaneously compared, the results can be extracted quickly, in a very reactive way. The unitary cost of a studied case is much less expensive in a registry than in a RCT. The nationwide registries such as the Scandinavian ones, perfectly describe the ‘real world’, much more than ‘artificial’ RCT. To ensure a sufficient level of evidence, the registries, given the lack or the ‘R’ of randomization, must be given the ‘C’ of controlled. The Hernia Club Registry has been built this way:1st Input control: Each participant accepts and signs charter of Quality stating that “all input must be registered consecutive, unselected, exhaustive and in real time” 2nd Follow-up (1, 2, 5-year) is obtained by a clinical research assistant, independent and blinded for the surgical procedure.3rd Control of the outcomes: by the ARC during the patient’s interview.This way the registries may take an important place next to the RCT.