Safety and Efficacy of Endoscopic Tattooing in Colorectal Surgery. India Ink vs Sterile Carbon Particle Suspension. Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- C reactive protein
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 100 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •histologically confirmed malignancy planned for an elective, segmental laparoscopic colectomy.
排除标准
- •emergency surgery open surgery immune depressant disease immune depressant medication
研究组 & 干预措施
India ink tattooing
Experimental group includes patients undergone to preoperative endoscopic tattooing with Sterile Carbon Particle Suspension.
干预措施: endoscopic tattooing (Procedure)
Sterile Carbon Particle Suspension tattooing
Control group includes patients undergone to preoperative endoscopic tattooing with India Ink.
干预措施: endoscopic tattooing (Procedure)
结局指标
主要结局
C reactive protein
时间窗: 24 hours after tattooing
Visibility of the tattoo
时间窗: During operative colectomy
Body Temperature
时间窗: 24 hours after tattooing
Abdominal pain
时间窗: 6 hours after tattooing
using VAS Scale (from 1 to 10)
White Blood Count
时间窗: 24 hours after tattooing
Peritoneal adhesions
时间窗: During operative colectomy
Intraoperative adhesions, detected during laparoscopy and classified using Zühlke classification ranging from 0 to 4
次要结局
未报告次要终点
研究者
Marco Milone
Principal investigator
Federico II University
