OP077: Feasibility and surgeon acceptability of visualisation with Lugol’s iodine (VILI) in the lihncs trial

Abstract

Residual margin dysplasia is a cause of disease failure in SCCHN. The LIHNCS trial is a multicenter randomized controlled trial (RCT) assessing the effectiveness of visualization with Lugol’s iodine (VILI) vital staining to reduce margin dyplasia at resection of Oral and Oropharyngeal squamous cell carcinoma (SCC). As part of this investigation we are investigating feasibility of the technique in head and neck surgical practice and the acceptability of the technique to surgeons. Questionnaire survey and telephone interviews were conducted with surgeons participating in the LIHNCS randomized controlled clinical trial. Data collected included surgeon views on trial participation, difficulties encountered in the trial processes including consent, maintenance of equipoise and randomization. Specific information on acceptability of the VILI technique was obtained and analysed. Twenty-three surgeons were recruiting to the study when this data was obtained. There was a high proportion of recognition of the importance of involving patients in RCTs. Some surgeons reported cases where patients refused participation and requested use of VILI rather than randomization in the trial. The VILI technique did not add significantly to overall surgical time. Further detailed analysis of surgeon acceptability will be presented. UK Head and Neck Surgeons recognize the high level importance of recruitment to clinical trials in surgery. Difficulties encountered in this trial have not restricted recruitment of eligible patients. The VILI technique has high acceptability among surgeons recruiting to the LIHNCS trial.