Surgical quality control in an international randomized clinical trial.

One of the current international prospective clinical trials of the EORTC Melanoma Cooperative Group explores the usage of regional isolated perfusion as adjuvant in melanomas located on the extremities. In the design of the study it is necessary to define not only the extent of the surgery (perfusion+local excision versus local excision only), but also to ensure uniformity of surgery performed between surgeons and institutions. With on-site visits and general meetings with the participants, surgical protocol violations and misinterpretations of the protocol could be avoided. The conclusion is that accurate surgical quality control is time consuming, but not difficult.