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临床试验/NCT04534816
NCT04534816已完成不适用

Feasibility and Usability of Intraoperative Fluorescent Angiography With Indocyanine Green in Penetrating Abdominal Trauma

Rigshospitalet, Denmark1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年3月12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
20
试验地点
1
主要终点
Feasibility and usability of ICG-FA

研究概览

简要总结

The surgical management of penetrating bowel and intestinal injuries, inflicted via a gunshot or knife stabbing, has long been a topic of debate [1-3]. The surgical management principally consists of: (i) primary repair; (ii) primary diversion or (iii) an initial abbreviated so called "damage control" operation followed by a definitive surgical intervention once the patient is stabilized [4-9] . Different classifications systems have been proposed to help determine the best operative option [2,3,10-14], but intestinal injuries can be difficult to manage and despite improvements in the diagnostics and treatment of penetrating abdominal trauma, high mortality and morbidity rates are prevalent [15,16]. In order to determine the correct surgical option an accurate determination of intestinal viability is essential. But clinically assessing regional perfusion is challenging and surgeons' clinical risk assessment of anastomotic leaks have shown a low predictive value [17]. Hence, there is a need for more precise diagnostic tool helping the surgeon in assessing intestinal viability the extent of intestinal injury.

Indocyanine green (ICG) fluorescence angiography (ICG-FA) is an applied method for to assessing visceral perfusion worldwide. The obtained fluorescent signal after intravenous injection, is considered proportional to blood flow, thus aiding the surgeon to detect and address inadequate regional perfusion, despite satisfactory macroscopic appearance, intraoperatively [18-21]. Hence, the use of perioperative ICG-FA, has reduced the risk of anastomotic leaks after esophageal and colorectal surgery [22-25] and in the setting of acute mesenteric ischemia, significantly reduced the extent of intestinal resection [26]. In retrospective review of 186 war related trauma cases the use of ICG-FA was deemed useful however only 9 of these cases were truncal/abdomen/gastrointestinal and no objective definition of usability was provided [27]. Hence, data on the usability and feasibility of ICG-FA for in penetrating abdominal trauma is limited and to our knowledge has not been investigate in a civilian population previously.

The present study aimed to investigate the usability and feasibility of ICG-FA in patients undergoing open abdominal exploration for penetrating abdominal trauma

详细描述

The surgical management of penetrating bowel and intestinal injuries has been the topic of debate since before the second world war [1-3]. The injury is most often inflicted via a gunshot or knife stabbing. Different classifications systems have been proposed to help determine the best operative option: (i) Flint Grading System (FGS); (ii) Penetrating Abdominal Trauma Index (PATI); (iii) Colonic/Rectal Injury Scale (CIS/RIS); and (iv) destructive/non-destructive colonic injuries; (v) Stone and Fabian's criteria [2,3,10-14].

Principally, a penetrating injury of the intestine can be managed by: (i) primary repair (suturing the hole in the intestine); (ii) primary diversion (the intestine, above the injury, is brought through the abdominal wall as a "stoma") or (iii) an abbreviated primary operation (laparotomy, where large bleeding is stopped and destroyed tissue is removed) and planned reoperation, within 24-48 hours, for definitive treatment (final treatment, for example reconnecting intestinal ends). The concept of abbreviated primary operation, also known as "damage control surgery", is today well established in trauma care [4-6]. A damage control operation with regards to intestinal injury, entails a primary resection/removal of the affected intestinal segment in which the remaining intestinal ends are closed off and not surgically connected (anastomosed) in the first operation.[4-9]. The abdomen is left "open" (the incision through the abdominal wall is not sutured closed but covered with a temporary dressing), and a relaparotomy (re-operation) is conducted once the patient is stabilized (at the end of which the abdominal wall is closed), usually after 24-48 h [4-9]. During the re-laparotomy, the intestines will then either be anastomosed (re-connected), or a stoma will be created if the intestine is deemed too damaged to be re-connected [4-9].

Non-destructive colonic injuries (Flint grades 1 & 2 and CIS grades I to III) are generally treated with primary repair, which involves the identification, debridement and single-layer suture repair of perforation and then dressing the repaired site with omentum (an intra-abdominal layer of fat and vessels) [1,2,10,12]. Primary repair is generally considered the better option in this setting [1-3,28].

Destructive colon wounds (Flint grade 3 or CIS grades IV and V) encompass those injuries that require segmental resection (parts of the large intestine have to be removed) due to extensive damage or loss of blood supply or both [10,12]. The management of destructive colon wounds is less clear and is still debatable. However, primary repair has been deemed as a safe option, while primary diversion has been opted for in particular cases [1-3,9,11,29-33]. In unstable patients; those with hypovolemic shock (large blood loss), blood-poisoning due to intestinal content leaking into the abdominal cavity, systemic hypothermia (low body temperature), and complex intra-abdominal injuries; an abbreviated laparotomy is considered to be an appropriate course of action [7,11,30,32-34].

In colonic trauma, the anastomosis leak rate (the connection between to intestinal ends breaks down) is reported between 4-27% [34-37]. A leak in the sight of intestinal connection is a severe complication which greatly increases the length of hospitalization, increases patient morbidity and has a significant negative impact on patient's recovery. The mortality rate for an anastomotic leak around 10-15% [38,39]. Factors associated with anastomotic failure include co-morbid immune-compromising disorders such as diabetes mellitus, acquired immunodeficiency syndrome, cirrhosis and a transfusion requirement of more than six units of blood [36]. Other potential risk factors appear to be shock, significant associated injuries, and delay of operation [35,36].

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
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

入选标准

  • Patients (above 18 years) scheduled for emergency laparotomy due to penetrating abdominal trauma

排除标准

  • Allergy towards; iodine, indocyanine green or shellfish
  • Liver insufficiency
  • Thyrotoxicosis
  • Pregnancy or lactation
  • Legally incompetent for any reason

结局指标

主要结局

Feasibility and usability of ICG-FA

时间窗: through study completion, an average of 1 year

Feasibility is defined as the completion rates of the ICG angiography. For each ICG assessment, the operating surgeon will be asked to fill out the widely used System Usability Scale (SUS®).

次要结局

  • Surgical management(through study completion, an average of 1 year)

研究者

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

JENS OSTERKAMP

M.D

Rigshospitalet, Denmark

研究点 (1)

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