Skip to content

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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03637933
Enrollment
50
Registered
2018-08-20
Start date
2017-06-01
Completion date
2018-12-01
Last updated
2018-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Safety and Efficacy of Tattooing Substance

Brief 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.

Interventions

PROCEDUREendoscopic 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.

Sponsors

Federico II University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

emergency surgery open surgery immune depressant disease immune depressant medication

Design outcomes

Primary

MeasureTime frameDescription
Abdominal pain6 hours after tattooingusing VAS Scale (from 1 to 10)
Body Temperature6 hours after tattooing
White Blood Count6 hours after tattooing
C reactive protein6 hours after tattooing
Peritoneal adhesionsDuring operative colectomyIntraoperative adhesions, detected during laparoscopy and classified using Zühlke classification ranging from 0 to 4
Visibility of the tattooDuring operative colectomy

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026