NCT03637933

Endoscopic Tattooing and Colorectal Cancer

Safety and Efficacy of Endoscopic Tattooing in Colorectal Surgery. India Ink vs Sterile Carbon Particle Suspension. Randomized Clinical Trial.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Federico II University · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Safety and Efficacy of Tattooing Substance

Interventions

Type	Name	Description
PROCEDURE	endoscopic tattooing	The tattoo has to be placed 1 or 2 cm distal to the lesion and tattooing has to be performed in at least 2 of the 4 quadrants of the bowel. A 0.5-1 mL saline bleb has to be raised submucosally and then a similar quantity of India Ink or Sterile Carbon Particle Suspension has to be injectiected into that bleb.

Timeline

• Start date: 2017-06-01
• Primary completion: 2018-11-01
• Completion: 2018-12-01
• First posted: 2018-08-20
• Last updated: 2018-12-20

Locations

1 site across 1 country: Italy