Endoscopic Tattooing and Colorectal Cancer

Study Overview
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Brief Summary
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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.

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

Conditions
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Safety and Efficacy of Tattooing Substance

Intervention / Treatment
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* Procedure: endoscopic tattooing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: histologically confirmed malignancy planned for an elective, segmental laparoscopic colectomy. Exclusion Criteria: emergency surgery open surgery immune depressant disease immune depressant medication

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: India ink tattooing<br>Experimental group includes patients undergone to preoperative endoscopic tattooing with Sterile Carbon Particle Suspension. | Procedure: endoscopic tattooing<br>* 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.<br>|
| Experimental: Sterile Carbon Particle Suspension tattooing<br>Control group includes patients undergone to preoperative endoscopic tattooing with India Ink. | Procedure: endoscopic tattooing<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abdominal pain | using VAS Scale (from 1 to 10) | 6 hours after tattooing | 
| Body Temperature |  | 6 hours after tattooing | 
| Body Temperature |  | 24 hours after tattooing | 
| White Blood Count |  | 6 hours after tattooing | 
| White Blood Count |  | 24 hours after tattooing | 
| C reactive protein |  | 6 hours after tattooing | 
| C reactive protein |  | 24 hours after tattooing | 
| Peritoneal adhesions | Intraoperative adhesions, detected during laparoscopy and classified using Zühlke classification ranging from 0 to 4 | During operative colectomy | 
| Visibility of the tattoo |  | During operative colectomy |