跳至主要内容
临床试验/NCT02102217
NCT02102217已完成不适用

PREdiction of Complications: A Step-up Approach, CRP First Followed by CT-scan Imaging to Ensure Quality Control After Major Abdominal Surgery

Amsterdam UMC, location VUmc2 个研究点 分布在 1 个国家目标入组 525 人开始时间: 2015年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
525
试验地点
2
主要终点
Morbidity and mortality after major complications

研究概览

简要总结

20% of patients who undergo major abdominal surgery will have a major complication, which requires invasive treatment and is associated with increased mortality, morbidity, hospital stay and intensive care stay. A quality control algorithm after Major Abdominal Surgery (MAS) aimed at early identification of patients at risk of developing major complications can decrease associated morbidity and mortality. Literature studies show promising results for C-reactive protein as an early marker for postoperative complications, however clinical significance has yet to be determined. Here the investigators propose a randomized clinical trial in order to determine the effect of postoperative monitoring with standardized CRP measurements on postoperative morbidity and mortality, if CRP levels exceed 140 mg/L additional CT-scan imaging will be conducted.

详细描述

Major Abdominal Surgery (MAS) may be defined as a surgical resection performed on colorectal, hepato-pancreatico-biliary and upper-GI organs with either primary anastomosis and/or ostomy. In patients undergoing MAS postoperative complications are reported in up to 40% of patients. Around 20% of all MAS patients have a major complication, which requires invasive treatment such as reoperation, percutaneous drainage and intensive care admission. Major complications further increase morbidity and mortality after major abdominal surgery, leading to longer intensive care and hospital stay, unplanned open procedures and creation of ostomies and possible increased cancer recurrence rates and costs.

In current postoperative practice median time to clinical diagnosis of a postoperative complication is approximately eight days. A delay in diagnosis of complications increases morbidity and mortality related to major complications. Whereas early diagnosis of postoperative septic complications, before clinical deterioration, is associated with a decrease in the associated morbidity and mortality. An early detection of septic complications is challenging and may clinically and serologically, as well while using imaging techniques, be hard to distinguish from the physiological and postoperative systemic inflammatory response syndrome (SIRS). Furthermore clinical risk assessment appears to have a low predictive value for major complications such as anastomotic leak. This further stresses the need for a standardized Quality Control algorithm after MAS.

Noteworthy is that nowadays no standard Quality Control tests or protocols are available after MAS to differentiate between a normal and a complicated postoperative course.

In the search for a marker in early diagnosis of postoperative complications several biomarkers have been assessed, such as interleukin 6 (IL-6), Tumour necrosis factor α (TNF-α), procalcitonin, white blood cell count (WBC) and C-reactive protein (CRP).

WBC showed no significant differences between patients with an uncomplicated versus complicated postoperative course. WBC is therefore not useful in a standardized quality control algorithm. Procalcitonin, IL-6 and TNF-α have been assessed as markers of postoperative sepsis. However, compared to CRP they achieve similar results in predicting major complications after MAS. Moreover, taking into account the higher cost and limited availability of testing for procalcitonin, IL-6 and TNF-α levels, we further focussed on the use of CRP in a postoperative standardized quality control algorithm.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
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

  • Age equal to or above 18 years
  • Planned elective MAS
  • Written and oral informed consent

排除标准

  • Acute MAS
  • ASA classification equal to four or higher
  • Insufficient Dutch language skills
  • contrast allergies
  • glomerular filtration rate (GFR) < 60 ml/min/1,73m2

结局指标

主要结局

Morbidity and mortality after major complications

时间窗: one year

Combined Primary outcome, entailing both: 1. Mortality; during 12 month follow-up 2. Morbidity associated with major complications and after reoperation within 12 months after index operation. Including: Fistula, Wound dehiscence/incisional hernia/open abdomen, bowel obstruction or herniation, abscess, abdominal compartment syndrome, perforation of visceral organ, unplanned enterostomy, enterostomy dysfunction due to prolapse, stenosis or retraction, myocardial infarction, pulmonary embolus, respiratory insufficiency; necessitating mechanical ventilation, cerebrovascular accident, renal failure, urosepsis; urinary tract infection with positive urine and blood cultures and circulatory shock, upper GI bleeding needing intervention of any type, intra-abdominal bleeding, anastomotic leak after relaparotomy

次要结局

  • Quality of life questionnaires(3,5 days, 3 and 12 months postoperatively)
  • Add-on value of CRP(postoperative days 3,4 and 5)
  • Length of stay(Up to one year after randomization)
  • Length of Intensive Care admission(up to one year after randomization)
  • Cost-efficiency(one year)

研究者

发起方
Amsterdam UMC, location VUmc
申办方类型
Other
责任方
Principal Investigator
主要研究者

J. Straatman

Drs. J. Straatman

Amsterdam UMC, location VUmc

研究点 (2)

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