Perfusion Evaluation by Real-time Fluorescence-based Enhanced Reality of Anastomosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Correlation between the perfusion evaluated by the ICG fluorescence-based enhanced reality and the metabolic state of the intestine
研究概览
简要总结
The aim of this study is to evaluate the ability of a ICG-fluorescence guidance complemented with enhanced reality to correctly document intestinal pre-anastomotic perfusion and to validate the accuracy of this technique with metabolic intestinal cells changes.
详细描述
Accurate intraoperative evaluation of peri-anastomotic gastrointestinal tract perfusion is essential to reduce the risk of anastomotic complications such as leakage or strictures. Anastomotic leakage is the most dreadful complication of colorectal resections.
Intestinal microcirculation and viability is usually estimated from the color of the serosal surface, presence of peristalsis, pulsation and bleeding from the marginal arteries. This is subjective and based on the experience of the surgeon.
Fluorescence videography integrates a near-infrared endoscope able to detect the signal emitted by a fluorescent dye, Indocyanine Green (ICG), which is administered by intravenous injection. Fluorescence intensity is proportional to the amount of fluorescent dye diffused in the tissue and it consequently is a surrogate marker of tissue perfusion.
The hypothesis is that ICG-fluorescence guidance coupled with enhanced reality would allow a precise and rapid localization of the future anastomotic site in terms of optimal perfusion in laparoscopic colorectal resections.
In patients undergoing elective left-sided colonic resection by laparoscopic approach, resection site and anastomosis perfusion will be evaluated by :
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient, male or female, from 18 years old
- •Patient with sigmoid diverticulosis or diverticulitis
- •Patient with colon malignancy
- •Patient with rectum malignancy
- •Patient with no contraindication to anesthesia and to colonic resection surgery
- •Patient able to understand the study and to provide informed consent
- •Patient affiliated to the French social security system
排除标准
- •Patient undergoing emergency surgery
- •Patient undergoing abdomino-perineal resection
- •Patient undergoing colonic resection without anastomosis (Hartmann's colostomy)
- •Patient with proven or unclear allergic reactions
- •Pregnancy or breast-feeding
- •Patient in exclusion period (determined by a previous study or in progress)
- •Patient in custody
- •Patient under guardianship
结局指标
主要结局
Correlation between the perfusion evaluated by the ICG fluorescence-based enhanced reality and the metabolic state of the intestine
时间窗: During surgery
The perfusion evaluated by the ICG fluorescence-based enhanced reality, obtained by the digital process of the fluorescence dynamic signal, will be correlated to the metabolic state of the intestine, assessed by the measure of biological markers on several points of the intestine.
次要结局
- Correlation between the intraoperative intestinal perfusion and the rate of anastomosis leakage(During surgery)
- Distance between the resection site based on the surgeon's appreciation and the resection site based on the digital analysis and the peri-operative samplings(During surgery)