GESEMM: Gastrointestinal Emergency Surgery: Evaluation of Morbidity and Mortality
Study Details
Study Description
Brief Summary
Gastrointestinal Emergency Surgery: Evaluation of Morbidity and Mortality
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Detailed Description
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
Study Design
Outcome Measures
Primary Outcome Measures
- 30-day mortality rate [18 months]
any cause of mortality related to surgical procedure
- 30-day morbidity rate [18 months]
Morbidity defined by mean of the Clavien's Classification scoring system
Secondary Outcome Measures
- Calculation of Charlson Age-Comorbidity Index (CACI) [8 months]
Calculation and evaluation of its predictive value for morbidity and mortality
- Simplified Acute Physiology Score-II (SAPS-II) [18 months]
Calculation and evaluation of its predictive value for mortality
- American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) surgical risk calculator [18 months]
Calculation and evaluation of its predictive value for post-operative complications
- 5-item Frailty Index [18 months]
Frailty stratification in participants
- Total number of subjects underwent emergency surgery [18 months]
Number of patients submitted to surgery
- Emergency Surgical Frailty Index (EmFSI) [18 months]
Frailty stratification in participants
Eligibility Criteria
Criteria
Inclusion Criteria:
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18 y.o. completed at the day of surgery
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Emergency gastrointestinal surgery considered as not-scheduled procedure
Exclusion Criteria:
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Age under 18 y.o. at the day of surgery
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Lack of informed consent
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Patients already hospitalized and scheduled for the same procedure
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Participation in another trial.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Università Campus Biomedico | Rome | Lazio | Italy | 00136 |
Sponsors and Collaborators
- Campus Bio-Medico University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 87/21 (OSS)