Completed

NCT Number: NCT03637933

Endoscopic Tattooing and Colorectal Cancer

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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Key information

Conditions

Safety and Efficacy of Tattooing Substance

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Naples Federico II

Naples, 80131, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

histologically confirmed malignancy planned for an elective, segmental laparoscopic colectomy.

Exclusion criteria

emergency surgery open surgery immune depressant disease immune depressant medication

Treatment and study plan

endoscopic tattooing

Procedure

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.

Primary outcomes

Abdominal pain

Time frame: 6 hours after tattooing

using VAS Scale (from 1 to 10)
Body Temperature

Time frame: 6 hours after tattooing
Body Temperature

Time frame: 24 hours after tattooing
White Blood Count

Time frame: 6 hours after tattooing
White Blood Count

Time frame: 24 hours after tattooing
C reactive protein

Time frame: 6 hours after tattooing
C reactive protein

Time frame: 24 hours after tattooing
Peritoneal adhesions

Time frame: During operative colectomy

Intraoperative adhesions, detected during laparoscopy and classified using Zühlke classification ranging from 0 to 4
Visibility of the tattoo

Time frame: During operative colectomy

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

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

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2018
First posted: Aug 20, 2018
Registry last updated: Dec 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.