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临床试验/NCT04766060
NCT04766060已完成不适用

Indocyanine Green Enhanced Fluorescent Angiography: Can it Predict Anastomotic Leakage (AL) After Recto-sigmoid Resection for Malignancy, and Are we Able to Evaluate the Findings? -A Small Multi-centre Trial Study

Odense University Hospital1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2017年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
55
试验地点
1
主要终点
Number of patients with anastomotic leakage and evaluation of fluorescent imaging in these patients

研究概览

简要总结

A serious complication to colorectal surgery is anastomotic leakage (AL). AL increases post-operative mortality, decreases long-term survival, reduces the functional result and reduces qual-ity of life. Studies suggest that performing an indocyanine-green enhanced fluorescent angi-ography (ICGeFA), blood perfusion in the bowel can be visualised. It is suggested that using this procedure the relative risk of AL is reduced about 54-67%.

With this project we wish to evaluate the feasibility of the procedure, and, if proven feasible, to plan further studies evaluating the procedure.

详细描述

Colorectal cancer is one of the most common cancer-diagnosis in Denmark. In 2014, 5186 pa-tients with colorectal cancer were registered. 1674 patients had cancer in the rectum and 1316 in the sigmoid colon. 668 patients underwent surgery with low anterior resection (LAR) and primary anastomosis, and 850 patients had a sigmoid resection with primary anastomosis.

A serious complication is anastomotic leakage (AL). In 2014 a total of 67 (10%) patients were registered with AL.

In general AL increases the post-operative mortality, decreases long-term survival and reduces the functional result and thereby reduces quality of life.

Due to the possible severity of AL all measures possible should be taken to ensure an early diag-nosis and timely treatment, as this has been shown to reduce morbidity and mortality. The symp-toms of AL are uncharacteristic; the diagnosis cannot only rely on the development of clinical symptoms. However, specific clinical scoring symptoms, measuring C-reactive protein (CRP) and radiologic examinations are proven useful.

Treatment of AL varies with the degree of leakage, from conservative treatment with rectal lavage, endo-VAC therapy, drainage of abscesses, re-laparoscopy or laparotomy with a diverting stoma, and finally to break down the anastomosis and creating a temporary or permanent colostomy, all procedures with or without antibiotic treatment.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • robotic surgery for rectal cancer and cancers located low in the sigmoid bowel

排除标准

  • Allergy of iodide
  • Pregnancy
  • Lactation

结局指标

主要结局

Number of patients with anastomotic leakage and evaluation of fluorescent imaging in these patients

时间窗: 30 days

Primary surgeons peroperative evaluation of fluoresence

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Pernille Larsen

Medical Doctor

Odense University Hospital

研究点 (1)

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