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Gastrointestinal InjuryGESEMMNCT05226221

Gastrointestinal Emergency Surgery: Evaluation of Morbidity and Mortality

An observational study of Gastrointestinal Injury and Gastrointestinal Hemorrhage, run by Campus Bio-Medico University at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Gastrointestinal Emergency Surgery: Evaluation of Morbidity and Mortality Read more about this study

Who is it for?
Ages 18 years and older
How many people
200 participants
Where
1 siteItaly
Study dates
1 Sep 2021to 31 Aug 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Multicenter italian national survey cohort study

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Gianluca Costa, MD, PhD contact

+3903921119067

gianlucacostaphd@gmail.com

Italy1 site, 1 recruiting

  • Università Campus Biomedico

    Rome, Lazio, 00136

    Gianluca Costa, MD, PhD, g.costa@policlinicocampus.it

    Gabriella Teresa Capolupo, MD, PhD

    Recruiting

Other trials in Italy

About this study

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

Gastrointestinal Emergency Surgery: Evaluation of Morbidity and Mortality

Read the 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

Keywords
gastrointestinal emergency, acute care surgery
Medical subject headings
Gastrointestinal Hemorrhage, Gastrointestinal Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 30-day mortality rate

    any cause of mortality related to surgical procedure

    Measured: 18 months

  2. 30-day morbidity rate

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

    Measured: 18 months

Secondary outcomes (6)

  1. Calculation of Charlson Age-Comorbidity Index (CACI)

    Calculation and evaluation of its predictive value for morbidity and mortality

    Measured: 8 months

  2. Simplified Acute Physiology Score-II (SAPS-II)

    Calculation and evaluation of its predictive value for mortality

    Measured: 18 months

  3. 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

    Measured: 18 months

  4. 5-item Frailty Index

    Frailty stratification in participants

    Measured: 18 months

  5. Total number of subjects underwent emergency surgery

    Number of patients submitted to surgery

    Measured: 18 months

  6. Emergency Surgical Frailty Index (EmFSI)

    Frailty stratification in participants

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2022
  2. Study start1 Sep 2021
  3. Primary completion30 Aug 2023
  4. Study completion31 Aug 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05226221
Sponsor's protocol ID
87/21 (OSS)
Acronym
GESEMM
Status last verified
Feb 2024
First submitted
18 Jan 2022
Last updated
7 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 33738537

  • 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.

    PubMed 33205380

  • 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.

    PubMed 32737706

  • 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.

    PubMed 32675754

  • 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.

    PubMed 32088854

Questions about this trial

What is this clinical trial studying?

An observational study of Gastrointestinal Injury and Gastrointestinal Hemorrhage, run by Campus Bio-Medico University at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Gianluca Costa, MD, PhD (+3903921119067, gianlucacostaphd@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

30-day mortality rate (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05226221, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.

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