跳至主要内容
临床试验/NCT05226221
NCT05226221招募中不适用

Mortality and Morbidity in Emergency Gastrointestinal Surgery: Comparison of Different Incidence of Interventions According to the ICD-9-CM Classification in Relation to the Age Groups

Campus Bio-Medico University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
1
主要终点
30-day mortality rate

研究概览

简要总结

Gastrointestinal Emergency Surgery: Evaluation of Morbidity and Mortality

详细描述

Background: Gastrointestinal emergencies (GE) are frequently encountered in the emergency department (ED), and patients can present with wide-ranging symptoms. Symptoms that suggest an underlying GE can include: abdominal pain; nausea; vomiting; diarrhoea; melaena; haematemesis; constipation; jaundice; and abdominal distension. Abdominal pain is a common ED presentation and can be the cause of a wide variety of GE. The acute abdomen (AB) is a term given to sudden severe pain in the abdomen requiring fast diagnosis and treatment usually requiring emergency surgical procedures. Causes of AB may include: appendicitis; pancreatitis; peptic ulcer disease (PUD); gall bladder pathology; intestinal ischemia; diverticulitis; intestinal obstruction; and ruptured ectopic pregnancy. Emergency gastrointestinal surgery (EGS) is burdened by significant mortality and morbidity rates because it is performed with little to no advance planning or preparation, on patients who are in dire straits. Scott JW et al report that there are more than 3 million patients admitted to US hospitals each year for EGS diagnoses, more than the sum of all new cancer diagnoses. (Scotte JW) In addition to the complexity of the urgent surgical patient (often suffering from multiple co-morbidities), there is the unpredictability and the severity of the event. Frequently, it is necessary rapid decision-making that allows a correct diagnosis and an adequate and timely treatment. (See Ref.) Moreover, another study by Havens JM et al reported that patients undergoing EGS operation are up to 8 times more likely to die postoperatively than are patients undergoing the same procedures electively. Furthermore, the increase in average life will lead more and more people over 65 to face surgical pathologies in an emergency setting, and in the elderly EGS is characterized by greater morbidity and mortality as well as by a global worsening of the residual quality of life (QoL). The explanation for the high percentage of acute complications could be found in the inevitable reduction of the functional reserve related to age. An example is the reduction of the body's immune defenses in the humoral response of B cells, in the cell-mediated immune function and macrophage activity which explains the susceptibility to infectious complications, facilitated by the altered integrity of the skin barrier and mucous membranes too. Is in this setting that tools capable to help the surgeon in the decision-making process in order to reduce mortality and morbidity linked to the EGS could become very useful. To do this, it is necessary to study the greatest number of risk factors associated with EGS, considering all age groups and all types of diseases.

AIM: To analyze the clinicopathological findings, management strategies, and short-term outcomes of gastrointestinal emergency procedures; to evaluate the prognostic role of existing risk-scores; to define the most suitable scoring system or gastro-intestinal surgical emergency; to identify any specific parameters that may be used as variables for a new scoring system, peri-operative variables predicting adverse results and any critical issues in the management of these patients.

STUDY DESIGN: both retrospective and prospective cohort, multicenter, observational, no profit clinical study. All the study participants will collect data on > 18 y. o. patients underwent general emergency surgery during an 18 month period, guaranteeing whole completeness of the picked data > 95%. This study was approved by the Health Sciences Research Ethics Board of the University Campus Biomedio of Rome

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

  • 18 y.o. completed at the day of surgery
  • Emergency gastrointestinal surgery considered as not-scheduled procedure

排除标准

  • Age under 18 y.o. at the day of surgery
  • Lack of informed consent
  • Patients already hospitalized and scheduled for the same procedure
  • Participation in another trial.

结局指标

主要结局

30-day mortality rate

时间窗: 18 months

any cause of mortality related to surgical procedure

30-day morbidity rate

时间窗: 18 months

Morbidity defined by mean of the Clavien's Classification scoring system

次要结局

  • Emergency Surgical Frailty Index (EmFSI)(18 months)
  • Simplified Acute Physiology Score-II (SAPS-II)(18 months)
  • American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) surgical risk calculator(18 months)
  • 5-item Frailty Index(18 months)
  • Calculation of Charlson Age-Comorbidity Index (CACI)(8 months)
  • Total number of subjects underwent emergency surgery(18 months)

研究者

发起方
Campus Bio-Medico University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gianluca Costa

MD, PhD

Campus Bio-Medico University

研究点 (1)

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