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临床试验/NCT03637933
NCT03637933已完成不适用

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

Federico II University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年6月1日最近更新:
适应症
干预措施

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

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

Active Comparator

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

Experimental

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

发起方
Federico II University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marco Milone

Principal investigator

Federico II University

研究点 (2)

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