Clinical trial NCT03637933: Endoscopic Tattooing and Colorectal Cancer
Official title: Safety and Efficacy of Endoscopic Tattooing in Colorectal Surgery. India Ink vs Sterile Carbon Particle Suspension. Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Safety and Efficacy of Tattooing Substance
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2018-08-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

emergency surgery open surgery immune depressant disease immune depressant medication

Primary outcomes:
measure: Abdominal pain
timeFrame: 6 hours after tattooing
measure: Body Temperature
timeFrame: 6 hours after tattooing
measure: Body Temperature
timeFrame: 24 hours after tattooing
measure: White Blood Count
timeFrame: 6 hours after tattooing
measure: White Blood Count
timeFrame: 24 hours after tattooing
measure: C reactive protein
timeFrame: 6 hours after tattooing
measure: C reactive protein
timeFrame: 24 hours after tattooing
measure: Peritoneal adhesions
timeFrame: During operative colectomy
measure: Visibility of the tattoo
timeFrame: During operative colectomy
Secondary outcomes:
Other outcomes:
Locations:
city: Naples
country: Italy
facility: University of Naples Federico II
Study officials:
References:
citation: Milone M, Vignali A, Manigrasso M, Velotti N, Sarnelli G, Aprea G, De Simone G, Maione F, Gennarelli N, Elmore U, De Palma GD. Sterile carbon particle suspension vs India ink for endoscopic tattooing of colonic lesions: a randomized controlled trial. Tech Coloproctol. 2019 Nov;23(11):1073-1078. doi: 10.1007/s10151-019-02101-y. Epub 2019 Oct 30.