NCT05639920

Brief Summary

To assess the accuracy of Emergency Surgery Score in predicting postoperative morbidity and mortality in emergency laparotomy.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
138

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2023

Status
unknown

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

First Submitted

Initial submission to the registry

October 26, 2021

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

December 7, 2022

Completed
25 days until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

December 7, 2022

Status Verified

December 1, 2022

Enrollment Period

1 year

First QC Date

October 26, 2021

Last Update Submit

December 3, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • validity of emergency surgery score in laparotomies surgeries. .Emergency surgery score the minimum value 3 and maximum value 29 , and the higher scores mean a worse outcome

    Emergency surgery score the minimum value 3 and maximum value 29 , and the higher scores mean a worse outcome. Score includes demographics (e.g., age, race, sex), comorbidities (e.g chronic obstructive pulmonary disease \[COPD\], hypertension, ascites), functional status, and preoperative laboratory variables (e.g sodium, albumin, and WBC count). Laboratory values are divided into low, normal, and high (where applicable) using clinically relevant cutoffs. Demographic factors and comorbid conditions are dichotomized using ACS-NSQIP definitions of normal and abnormal. Age will dichotomiz into younger or older than 60 years ; race, into white or colored ; "partially" or "totally" dependent is deemed as functional dependence; and dyspnea with moderate exertion or rest was classified as dyspnea. Body mass index is divided into less than 20, 20 to 35, or greater than 35 kg/m2 . Laboratory values are divided into low, normal, and high using the NSQIP definitions.

    "through study completion, an average of 1 year".

Secondary Outcomes (2)

  • mortality rate in emergency laparotomies surgeries.

    1 year

  • morbidity rate in emergency laparotomies surgeries.

    1 year

Study Arms (1)

Group A

Combination Product: Scoreing

Interventions

ScoreingCOMBINATION_PRODUCT

Validation of Emergency surgery score in predicting mortality and mortality in Egyptian patients undergoing Emergency laparotomy

Group A

Eligibility Criteria

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

Patients \>18 years undergoing emergant laparotomies will be investigated to predict postoperative mortality and morbidity ESS is based on 22 independent predictors of mortality in Emergency surgery patients, including 3 demographic variables, 10 comorbidities, and 9 preoperative laboratory variables. The score ranges from 0 to 29 and can be calculated from information obtained from a patient's history and routine laboratory tests. ESS aims to accurately predict postoperative mortality in patients undergoing ES and has been suggested as a tool for surgical quality benchmarking, as well as for preoperative patient and family counseling. In the validation study, ESS had a c-statistic of 0.86, suggesting that it performs remarkably well as a mortality risk calculator.11

You may qualify if:

  • Patients more who are 18 years old or older.
  • Patients who are in need of an emergency laparotomy within 24 hours of admission.

You may not qualify if:

  • Patients less than 18 years old.
  • Patients who are not accessible for follow up to the 30th postoperative day.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (12)

  • Nag DS. Assessing the risk: Scoring systems for outcome prediction in emergency laparotomies. Biomedicine (Taipei). 2015 Dec;5(4):20. doi: 10.7603/s40681-015-0020-y. Epub 2015 Nov 28.

    PMID: 26615537BACKGROUND
  • Saunders DI, Murray D, Pichel AC, Varley S, Peden CJ; UK Emergency Laparotomy Network. Variations in mortality after emergency laparotomy: the first report of the UK Emergency Laparotomy Network. Br J Anaesth. 2012 Sep;109(3):368-75. doi: 10.1093/bja/aes165. Epub 2012 Jun 22.

    PMID: 22728205BACKGROUND
  • Rix TE, Bates T. Pre-operative risk scores for the prediction of outcome in elderly people who require emergency surgery. World J Emerg Surg. 2007 Jun 5;2:16. doi: 10.1186/1749-7922-2-16.

    PMID: 17550623BACKGROUND
  • Ahuja A, Pal R. Prognostic scoring indicator in evaluation of clinical outcome in intestinal perforations. J Clin Diagn Res. 2013 Sep;7(9):1953-5. doi: 10.7860/JCDR/2013/6572.3375. Epub 2013 Sep 10.

    PMID: 24179907BACKGROUND
  • Mercer S, Guha A, Ramesh V. The P-POSSUM scoring systems for predicting the mortality of neurosurgical patients undergoing craniotomy: Further validation of usefulness and application across healthcare systems. Indian J Anaesth. 2013 Nov;57(6):587-91. doi: 10.4103/0019-5049.123332.

    PMID: 24403619BACKGROUND
  • Neary WD, Heather BP, Earnshaw JJ. The Physiological and Operative Severity Score for the enUmeration of Mortality and morbidity (POSSUM). Br J Surg. 2003 Feb;90(2):157-65. doi: 10.1002/bjs.4041.

    PMID: 12555290BACKGROUND
  • Knaus WA, Wagner DP, Draper EA, Zimmerman JE, Bergner M, Bastos PG, Sirio CA, Murphy DJ, Lotring T, Damiano A, et al. The APACHE III prognostic system. Risk prediction of hospital mortality for critically ill hospitalized adults. Chest. 1991 Dec;100(6):1619-36. doi: 10.1378/chest.100.6.1619.

    PMID: 1959406BACKGROUND
  • Chang RW. Individual outcome prediction models for intensive care units. Lancet. 1989 Jul 15;2(8655):143-6. doi: 10.1016/s0140-6736(89)90193-1.

    PMID: 2567904BACKGROUND
  • Kongkaewpaisan N, Lee JM, Eid AI, Kongwibulwut M, Han K, King D, Saillant N, Mendoza AE, Velmahos G, Kaafarani HMA. Can the emergency surgery score (ESS) be used as a triage tool predicting the postoperative need for an ICU admission? Am J Surg. 2019 Jan;217(1):24-28. doi: 10.1016/j.amjsurg.2018.08.002. Epub 2018 Aug 23.

    PMID: 30172358BACKGROUND
  • Peponis T, Bohnen JD, Sangji NF, Nandan AR, Han K, Lee J, Yeh DD, de Moya MA, Velmahos GC, Chang DC, Kaafarani HMA. Does the emergency surgery score accurately predict outcomes in emergent laparotomies? Surgery. 2017 Aug;162(2):445-452. doi: 10.1016/j.surg.2017.03.016. Epub 2017 May 26.

    PMID: 28554491BACKGROUND
  • Vasileiou G, Ray-Zack M, Zielinski M, Qian S, Yeh DD, Crandall M. Validation of the American Association for the Surgery of Trauma emergency general surgery score for acute appendicitis-an EAST multicenter study. J Trauma Acute Care Surg. 2019 Jul;87(1):134-139. doi: 10.1097/TA.0000000000002319.

    PMID: 31259871BACKGROUND
  • Montasser M, Ellisy DAM, Sayed JA, Makkey MM. Validation of Emergency Surgery Score (ESS) as outcome prediction score in Egyptian patients undergoing emergency laparotomy. Int J Emerg Med. 2025 Jul 7;18(1):124. doi: 10.1186/s12245-025-00934-z.

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

October 26, 2021

First Posted

December 7, 2022

Study Start

January 1, 2023

Primary Completion

January 1, 2024

Study Completion

February 1, 2024

Last Updated

December 7, 2022

Record last verified: 2022-12