Endoscopic Tattooing and Colorectal Cancer
- Conditions
- Safety and Efficacy of Tattooing Substance
- Interventions
- Procedure: endoscopic tattooing
- Registration Number
- NCT03637933
- Lead Sponsor
- Federico II University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
histologically confirmed malignancy planned for an elective, segmental laparoscopic colectomy.
emergency surgery open surgery immune depressant disease immune depressant medication
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sterile Carbon Particle Suspension tattooing endoscopic tattooing Control group includes patients undergone to preoperative endoscopic tattooing with India Ink. India ink tattooing endoscopic tattooing Experimental group includes patients undergone to preoperative endoscopic tattooing with Sterile Carbon Particle Suspension.
- Primary Outcome Measures
Name Time Method C reactive protein 24 hours after tattooing Visibility of the tattoo During operative colectomy Abdominal pain 6 hours after tattooing using VAS Scale (from 1 to 10)
Body Temperature 24 hours after tattooing White Blood Count 24 hours after tattooing Peritoneal adhesions During operative colectomy Intraoperative adhesions, detected during laparoscopy and classified using ZĂĽhlke classification ranging from 0 to 4
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Naples Federico II
🇮🇹Naples, Italy