Safety and feasibility of a new rectoscope in rectal cancer surgery. First clinical trial

Abstract

We present a first in human clinical trial of a new rectoscope that shows, by means of transillumination, the optimal point of transection of the rectum in oncologic surgery. The device was developed together with a team of engineers and was manufactured by 3D printing. Eighteen patients with a mean age of 71 years and a mean distance from the tumor to the anal margin measured by colonoscopy of 10.4 ± 3.9 cm and by MRI of 10 ± 2.4 cm were included in the trial. Transillumination was feasible in all cases, and the use of the rectoscope was safe, as no adverse events due to its use were recorded.