Response to letter to the editor re 'catheter-directed foam sclerotherapy of great saphenous veins in combination with pre-treatment reduction of the diameter employing the principals of perivenous tumescent local anesthesia'

摘要

Thank you very much for your letter that highlights the positive effect of adding tumescence to foam sclerotherapy. When we designed the study as a prospective randomized controlled pilot trial employing the use of drugs (poli-docanol) we had to announce the protocol to the Federal Institute for Drugs and Medical Devices (BfArM, Bonn, Germany). This institute is defined as an independent federal higher authority within the portfolio of the Federal Ministry of Health. Following the device of the BfArM, we were not allowed to use our standard tumescence local anesthesia that we use routinely in endovenous thermal ablation settings. In contrast we were explicitly allowed only to inject saline solution perivenously. Maybe our results are influenced by this restriction.