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临床试验/NCT02598414
NCT02598414Unknown2 期

The Role of Indocyanine Green (ICG) Fluorescence Imaging on Anastomotic Leak and Short-term Outcomes in Robotic Colorectal Surgery: A Prospective Randomized Trial

Acibadem University1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2015年11月1日最近更新:
适应症

试验速览

阶段
2 期
发起方
入组人数
102
试验地点
1
主要终点
Anastomotic leak rate

研究概览

简要总结

In colorectal surgery, anastomotic leak and its septic consequences still remain as the most concerning complications resulting in substantial morbidity and mortality. A common determining factor for assessing the viability of a bowel anastomosis is adequate arterial perfusion to ensure sufficient local tissue oxygenation. Intraoperative near-infrared fluorescence (INIF) imaging using indocyanine green (ICG) dye is a novel technique which allows the surgeon to choose the point of transection at an optimally perfused area before creating a bowel anastomosis. Recently, the INIF imaging system has been installed on the robotic systems and this helps identify intravascular NIF signals in real time.

Although reports from several case series and retrospective cohorts have described the feasibility and safety of this imaging system during robotic colorectal surgery, to date, no studies have addressed more systematically the outcomes of this technique in robotic surgery. Considering the limitations of these reports, investigators aim to conduct a prospective randomized trial to compare robotic procedures with or without INIF imaging in patients undergoing colorectal surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

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

  • Subject is able to give informed consent for participation in the study
  • Subject is willing and able to comply with the study procedures
  • Subject is diagnosed with colon/rectal neoplasia, inflammatory bowel disease, diverticular disease requiring surgical excision
  • Subject is scheduled for robotic colon or rectal resection
  • A negative pregnancy test for women of childbearing potential prior to surgery

排除标准

  • Subjects present with bowel obstruction or perforation
  • Subject undergo emergency surgery
  • Subject with ASA IV, V
  • History of allergy or hypersensitivity against indocyanine green
  • Pregnant or breast-feeding women
  • Subject has uremia (serum creatinine >2.5 mg/dl)
  • Subject is undergoing palliative surgery or who is terminally ill
  • Subject who is unable to discontinue warfarin anticoagulation 5 days before surgery
  • Subject taking phenobarbital, phenylbutazone, primidone, phenytoin, haloperidol, nitrofurantoin, probenecid

结局指标

主要结局

Anastomotic leak rate

时间窗: Postoperative 30 days

Anastomotic leak rate within 30 post operative days

次要结局

  • Complication rate(Postoperative 30 days)
  • Mortality(Postoperative 30 days)

研究者

发起方
Acibadem University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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