Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2026-03-02 @ 3:59 PM
Study NCT ID:
NCT03637933
Status:
COMPLETED
Last Update Posted:
2018-12-20
First Post:
2018-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endoscopic Tattooing and Colorectal Cancer
Sponsor:
Federico II University
Organization:
Study Overview
Official Title:
Safety and Efficacy of Endoscopic Tattooing in Colorectal Surgery. India Ink vs Sterile Carbon Particle Suspension. Randomized Clinical Trial.
Status:
COMPLETED
Status Verified Date:
2018-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: