Safety and Efficacy of Tattooing Substance Clinical Trial
Official title:
Safety and Efficacy of Endoscopic Tattooing in Colorectal Surgery. India Ink vs Sterile Carbon Particle Suspension. Randomized Clinical Trial.
Endoscopic tattooing to facilitate colorectal lesions' identification during laparoscopic
surgery is a reliable and widely used technique.
India Ink is the standard option for colonic tattoing. Different studies have been reported
significant complications, of which the most common is peritonitis, due to ethylene glycol,
phenols and animal-derived gelatine contained in the ink. This local inflammatory reaction is
the principal reason of the formation of the adhesions detected during the laparoscopy, that
make the intervention more difficult. To prevent infection or inflammatory local reaction
India ink solution has to be sterilized and diluted, a cumbersome process. In the last years
wide diffusion of another endoscopic ink, Sterile Carbon Particle Suspension, has reduced
these complications. Sterile Carbon Particle Suspension is a prepackaged, sterile,
FDA-approved formulation of pure carbon particle in suspension, that eliminates the need for
preinjection preparation.
In an attempt to evaluate safety and efficacy of endoscopic tattooing in colorectal surgery
using two different types of ink, a randomized clinical trial has been designed. Two types of
endoscopic ink were evaluated: Sterile Carbon Particle Suspension (Experimental group) and
India Ink (Control group) and.
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