NCT05226221

Brief Summary

Gastrointestinal Emergency Surgery: Evaluation of Morbidity and Mortality

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 7, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2025

Completed
Last Updated

February 7, 2024

Status Verified

February 1, 2024

Enrollment Period

2 years

First QC Date

January 18, 2022

Last Update Submit

February 6, 2024

Conditions

Gastrointestinal InjuryGastrointestinal HemorrhageGastrointestinal LesionsGastrointestinal UlcerGastrointestinal PerforationGastrointestinal Cancer

Keywords

gastrointestinal emergency, acute care surgery

Outcome Measures

Primary Outcomes (2)

  • 30-day mortality rate

    any cause of mortality related to surgical procedure

    18 months

  • 30-day morbidity rate

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

    18 months

Secondary Outcomes (6)

  • Calculation of Charlson Age-Comorbidity Index (CACI)

    8 months

  • Simplified Acute Physiology Score-II (SAPS-II)

    18 months

  • American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) surgical risk calculator

    18 months

  • 5-item Frailty Index

    18 months

  • Total number of subjects underwent emergency surgery

    18 months

  • +1 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Multicenter italian national survey cohort study

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Università Campus Biomedico

Rome, Lazio, 00136, Italy

RECRUITING

Related Publications (5)

  • 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.

    PMID: 33738537RESULT

  • 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.

    PMID: 33205380RESULT

  • 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.

    PMID: 32737706RESULT

  • 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.

    PMID: 32675754RESULT

  • 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.

    PMID: 32088854RESULT

MeSH Terms

Conditions

Gastrointestinal HemorrhageGastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsDigestive System NeoplasmsNeoplasms by SiteNeoplasms

Central Study Contacts

Gianluca Costa, MD, PhD

CONTACT

+3903921119067gianlucacostaphd@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

January 18, 2022

First Posted

February 7, 2022

Study Start

September 1, 2021

Primary Completion

August 30, 2023

Study Completion

August 31, 2025

Last Updated

February 7, 2024

Record last verified: 2024-02

Locations

IT(1)