Prospective randomized study evaluating the usefulness of a surgical smoke evacuation system in operating rooms for breast surgery

BACKGROUND: No prospective evaluation of surgical smoke evacuation systems has yet been conducted anywhere in the world. A prospective randomized study was conducted to clarify the usefulness of a surgical smoke evacuation system in terms of reducing the quantity of environmental pollutants found in operating room air and reducing the occupational exposure of doctors and nurses involved in surgical procedures to surgical smoke, volatile organic compounds, formaldehyde, etc. METHODS: Operating room environment conditions with and without the use of a surgical smoke evacuation system were measured, and the personal exposure levels of doctors and nurses involved in surgical procedures were also surveyed. Use of the evacuation system was determined randomly, and the procedures involved were breast-conserving surgery and mastectomy, which were treated as stratification factors. RESULTS: The average total volatile organic compound concentration in the operating room was significantly lower when the evacuation system was used compared with when it was not used. The findings were similar for formaldehyde concentration. Multiple regression analysis for healthcare professionals’ personal exposure levels showed that the evacuation system was a factor that significantly impacted their formaldehyde and acetaldehyde personal exposure levels, which were greatly reduced by the use of the system. CONCLUSION: This study’s findings demonstrate the effectiveness of the evacuation systems, which should increase awareness that their benefits take priority over the drawbacks. TRIAL REGISTRATION: The study was conducted after explaining to participants that it was a study of operating room environments in which their participation was voluntary and obtaining their consent. The study was also approved by the Tokai University Hospital clinical research review committee (no. 5R-022) and registered with the UMIN registry (UMIN000029092) on 13, September, 2017- retrospectively registered.