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Gastrointestinal Emergency Surgery: Evaluation of Morbidity and Mortality

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05226221
Acronym
GESEMM
Enrollment
200
Registered
2022-02-07
Start date
2021-09-01
Completion date
2025-08-31
Last updated
2024-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Cancer, Gastrointestinal Hemorrhage, Gastrointestinal Injury, Gastrointestinal Lesions, Gastrointestinal Perforation, Gastrointestinal Ulcer

Keywords

gastrointestinal emergency, acute care surgery

Brief summary

Gastrointestinal Emergency Surgery: Evaluation of Morbidity and Mortality

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

Interventions

None listed

Sponsors

Campus Bio-Medico University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
30-day morbidity rate18 monthsMorbidity defined by mean of the Clavien's Classification scoring system
30-day mortality rate18 monthsany cause of mortality related to surgical procedure

Secondary

MeasureTime frameDescription
American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) surgical risk calculator18 monthsCalculation and evaluation of its predictive value for post-operative complications
5-item Frailty Index18 monthsFrailty stratification in participants
Calculation of Charlson Age-Comorbidity Index (CACI)8 monthsCalculation and evaluation of its predictive value for morbidity and mortality
Emergency Surgical Frailty Index (EmFSI)18 monthsFrailty stratification in participants
Total number of subjects underwent emergency surgery18 monthsNumber of patients submitted to surgery
Simplified Acute Physiology Score-II (SAPS-II)18 monthsCalculation and evaluation of its predictive value for mortality

Countries

Italy

Contacts

Primary ContactGianluca Costa, MD, PhD
gianlucacostaphd@gmail.com+3903921119067

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026