Gastrointestinal Emergency Surgery: Evaluation of Morbidity and Mortality (GESEMM)

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

Gastrointestinal Emergency Surgery: Evaluation of Morbidity and Mortality

Study Overview

• Status: Recruiting
• Conditions: Gastrointestinal Cancer; Gastrointestinal Hemorrhage; Gastrointestinal Lesions; Gastrointestinal Injury; Gastrointestinal Perforation; Gastrointestinal Ulcer

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 Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Gianluca Costa, MD, PhD; Phone Number: +3903921119067; Email: gianlucacostaphd@gmail.com

Study Locations

• Italy
  • Lazio
    • Rome, Lazio, Italy, 00136
      • Recruiting
      • Università Campus Biomedico
      • Contact: Gianluca Costa, MD, PhD; Email: g.costa@policlinicocampus.it
      • Sub-Investigator: Gabriella Teresa Capolupo, MD, PhD
      • Sub-Investigator: Filippo Carannante, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Multicenter italian national survey cohort study

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30-day morbidity rate	Morbidity defined by mean of the Clavien's Classification scoring system	18 months
30-day mortality rate	any cause of mortality related to surgical procedure	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Simplified Acute Physiology Score-II (SAPS-II)	Calculation and evaluation of its predictive value for mortality	18 months
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
Calculation of Charlson Age-Comorbidity Index (CACI)	Calculation and evaluation of its predictive value for morbidity and mortality	8 months
5-item Frailty Index	Frailty stratification in participants	18 months
Total number of subjects underwent emergency surgery	Number of patients submitted to surgery	18 months
Emergency Surgical Frailty Index (EmFSI)	Frailty stratification in participants	18 months

Collaborators and Investigators

• Sponsor: Campus Bio-Medico University

Publications and helpful links

General Publications

• 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 prospective study. Eur J Trauma Emerg Surg. 2022 Apr;48(2):1177-1188. doi: 10.1007/s00068-021-01645-9. Epub 2021 Mar 18.
• 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 internal validation of a novel simple bedside risk score for elderly patients undergoing emergency surgery. Aging Clin Exp Res. 2021 Aug;33(8):2191-2201. doi: 10.1007/s40520-020-01735-5. Epub 2020 Nov 18.
• 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 the elderly: multivariate analysis of morbidity and mortality from an Italian registry. Hernia. 2022 Feb;26(1):165-175. doi: 10.1007/s10029-020-02269-5. Epub 2020 Jul 31.
• 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 Analysis of the FRAILESEL Italian Multicenter Prospective Cohort Study. Surg Laparosc Endosc Percutan Tech. 2020 Jul 14;31(1):2-7. doi: 10.1097/SLE.0000000000000826.
• 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 Multicenter Prospective Cohort Study. Updates Surg. 2020 Jun;72(2):513-525. doi: 10.1007/s13304-020-00726-5. Epub 2020 Feb 22.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): August 30, 2023
• Study Completion (Estimated): August 31, 2025

Study Registration Dates

• First Submitted: January 18, 2022
• First Submitted That Met QC Criteria: February 1, 2022
• First Posted (Actual): February 7, 2022

Study Record Updates

• Last Update Posted (Estimated): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: gastrointestinal emergency, acute care surgery
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Disease Attributes; Digestive System Neoplasms; Gastrointestinal Diseases; Emergencies; Hemorrhage; Gastrointestinal Neoplasms; Gastrointestinal Hemorrhage
• Other Study ID Numbers: 87/21 (OSS)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No