Gastrointestinal Emergency Surgery: Evaluation of Morbidity and Mortality

Gastrointestinal Cancer Clinical Trial

— GESEMM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05226221
• Other study ID #: 87/21 (OSS)
• Status: Recruiting
• Start date: September 1, 2021
• Est. completion date: August 31, 2025

Study information

• Verified date: February 2024
• Source: Campus Bio-Medico University
• Contact: Gianluca Costa, MD, PhD
• Phone: +3903921119067
• Email: gianlucacostaphd[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Gastrointestinal Emergency Surgery: Evaluation of Morbidity and Mortality

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 31, 2025
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Emergencies
• Gastrointestinal Cancer
• Gastrointestinal Hemorrhage
• Gastrointestinal Injury
• Gastrointestinal Lesions
• Gastrointestinal Neoplasms
• Gastrointestinal Perforation
• Gastrointestinal Ulcer
• Hemorrhage

Locations

Country	Name	City	State
Italy	Università Campus Biomedico	Rome	Lazio

Sponsors (1)

Lead Sponsor	Collaborator
Campus Bio-Medico University

Country where clinical trial is conducted

Italy, 

References & Publications (5)

Ceresoli M, Carissimi F, Nigro A, Fransvea P, Lepre L, Braga M, Costa G; List of Elderly Risk Assessment and Surgical Outcome (ERASO) Collaborative Study Group endorsed by SICUT, ACOI, SICG, SICE, and Italian Chapter of WSES. Emergency hernia repair in th — View Citation

Costa G, Bersigotti L, Massa G, Lepre L, Fransvea P, Lucarini A, Mercantini P, Balducci G, Sganga G, Crucitti A; ERASO (Elderly Risk Assessment, Surgical Outcome) Collaborative Study Group. The Emergency Surgery Frailty Index (EmSFI): development and inte — View Citation

Costa G, Fransvea P, Podda M, Pisanu A, Carrano FM, Iossa A, Balducci G, Agresta F; ERASO (Elderly Risk Assessment and Surgical Outcome) Collaborative Study Group. The use of emergency laparoscopy for acute abdomen in the elderly: the FRAILESEL Italian Mu — View Citation

Fransvea P, Costa G, Lepre L, Podda M, Giordano A, Bellanova G, Agresta F, Marini P, Sganga G; ERASO (Elderly Risk Assessment and Surgical Outcome) Collaborative Study Group. Laparoscopic Repair of Perforated Peptic Ulcer in the Elderly: An Interim Analys — View Citation

Fransvea P, Fico V, Cozza V, Costa G, Lepre L, Mercantini P, La Greca A, Sganga G; ERASO study group. Clinical-pathological features and treatment of acute appendicitis in the very elderly: an interim analysis of the FRAILESEL Italian multicentre prospect — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30-day mortality rate	any cause of mortality related to surgical procedure	18 months
Primary	30-day morbidity rate	Morbidity defined by mean of the Clavien's Classification scoring system	18 months
Secondary	Calculation of Charlson Age-Comorbidity Index (CACI)	Calculation and evaluation of its predictive value for morbidity and mortality	8 months
Secondary	Simplified Acute Physiology Score-II (SAPS-II)	Calculation and evaluation of its predictive value for mortality	18 months
Secondary	American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) surgical risk calculator	Calculation and evaluation of its predictive value for post-operative complications	18 months
Secondary	5-item Frailty Index	Frailty stratification in participants	18 months
Secondary	Total number of subjects underwent emergency surgery	Number of patients submitted to surgery	18 months
Secondary	Emergency Surgical Frailty Index (EmFSI)	Frailty stratification in participants	18 months