EmergenciesNCT05639920
Validation of Emergency Surgery Score (ESS) in Egyptian Patients Undergoing Emergency Laparotomy
An observational study of Emergencies, run by Assiut University.
Trial summary
To assess the accuracy of Emergency Surgery Score in predicting postoperative morbidity and mortality in emergency laparotomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emergencies
- What is being tested?
- Scoreing
- How many people
- 138 participants
- Where
- No sites listed yet
- Study dates
- Jan 2023to Feb 2024
- How long will I take part?
- 30 Days
- 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: 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
Who may be able to join
- Patients more who are 18 years old or older.
- Patients who are in need of an emergency laparotomy within 24 hours of admission.
Who cannot join
- Patients less than 18 years old.
- Patients who are not accessible for follow up to the 30th postoperative day.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Validation of Emergency Surgery Score (ESS) as Outcome Prediction Score in Egyptian Patients Undergoing Emergency Laparotomy
To assess the accuracy of Emergency Surgery Score in predicting postoperative morbidity and mortality in emergency laparotomy.
Read the detailed description
Emergency laparotomy is the most common emergency surgery which considered a life saving exploratory procedure for which the clinical presentation, underlying pathology, anatomical site of surgery, and preoperative management vary considerably. There are more than 400 OPCS codes describing surgery that could come under the umbrella term of 'emergency laparotomy' which reflect the diverse nature of this surgical cohort. In spite the lack of data on the outcomes of emergency laparotomies it is generally considered very poor mortality rates following emergency laparotomy Internationally reported range from 13% to 18% at 30 days Even after innumerable advances in surgical skills, antimicrobial agents and supportive care. There is a need for early prognostic evaluation of these individuals to identify patients in high risk for more agressive treatment Using an ideal scoring system will help in ;.making appropriate decision on those patients. accurately predicting the risk of developing serious complications or die . Categorizing patients into different risk groups which would help to prognosticate the outcome, select patients for intensive care and determine operative risk, thereby helping to choose the nature of the operative procedure .
The Emergency Surgery Score (ESS) was developed as a novel preoperative risk assessment tool for patients undergoing EGS in 2016 ESS accurately predicts outcomes in all types of emergent laparotomy patients and may prove valuable as a bedside decision-making tool for patient and family counseling, as well as for adequate risk-adjustment in emergent laparotomy quality benchmarking efforts.10
- Conditions
- Emergencies
- Being tested
- Scoreing
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ScoreingCombination product
Validation of Emergency surgery score in predicting mortality and mortality in Egyptian patients undergoing Emergency laparotomy
| Study group | Role | What they receive |
|---|---|---|
| Group A | Not described Receives: Combination Product: Scoreing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: "through study completion, an average of 1 year".
Secondary outcomes (2)
mortality rate in emergency laparotomies surgeries.
case fatality rate in emergency laparotomies surgeries.
Measured: 1 year
morbidity rate in emergency laparotomies surgeries.
incidence of surgical site infection
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2022
- Study startJan 2023 (estimated)
- Primary completionJan 2024 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for EmergenciesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 138 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doaa Ahmed Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05639920
- Sponsor's protocol ID
- Emergency surgery score
- Status last verified
- Dec 2022
- First submitted
- 26 Oct 2021
- Last updated
- 7 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 26615537Saunders 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.
PubMed 22728205Rix 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.
PubMed 17550623Ahuja 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.
PubMed 24179907Mercer 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.
PubMed 24403619Neary 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.
PubMed 12555290Knaus 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.
PubMed 1959406Chang 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.
PubMed 2567904Kongkaewpaisan 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.
PubMed 30172358Peponis 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.
PubMed 28554491Vasileiou 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.
PubMed 31259871Montasser 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.
PubMed 40624475
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Emergency Surgery Score (ESS) as Outcome Prediction Score in Egyptian Patients Undergoing Emergency Laparotomy
- ClinicalTrials.gov ID
- NCT05639920
- Acronym / sponsor ID
- Emergency surgery score
- Conditions
- Emergencies
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2023 (estimated)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 7 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the accuracy of Emergency Surgery Score in predicting postoperative morbidity and mortality in emergency laparotomy.
Detailed description
Emergency laparotomy is the most common emergency surgery which considered a life saving exploratory procedure for which the clinical presentation, underlying pathology, anatomical site of surgery, and preoperative management vary considerably. There are more than 400 OPCS codes describing surgery that could come under the umbrella term of 'emergency laparotomy' which reflect the diverse nature of this surgical cohort. In spite the lack of data on the outcomes of emergency laparotomies it is generally considered very poor mortality rates following emergency laparotomy Internationally reported range from 13% to 18% at 30 days Even after innumerable advances in surgical skills, antimicrobial agents and supportive care. There is a need for early prognostic evaluation of these individuals to identify patients in high risk for more agressive treatment Using an ideal scoring system will help in ;.making appropriate decision on those patients. accurately predicting the risk of developing serious complications or die . Categorizing patients into different risk groups which would help to prognosticate the outcome, select patients for intensive care and determine operative risk, thereby helping to choose the nature of the operative procedure .
The Emergency Surgery Score (ESS) was developed as a novel preoperative risk assessment tool for patients undergoing EGS in 2016 ESS accurately predicts outcomes in all types of emergent laparotomy patients and may prove valuable as a bedside decision-making tool for patient and family counseling, as well as for adequate risk-adjustment in emergent laparotomy quality benchmarking efforts.10
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Combination Product: Scoreing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- Patients more who are 18 years old or older.
- Patients who are in need of an emergency laparotomy within 24 hours of admission.
Key exclusion criteria (2 listed)
- Patients less than 18 years old.
- Patients who are not accessible for follow up to the 30th postoperative day.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ScoreingValidation of Emergency surgery score in predicting mortality and mortality in Egyptian patients undergoing Emergency laparotomy | Combination product | Group A |
Primary outcome
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
Time frame: "through study completion, an average of 1 year".
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.
2 secondary outcomes
mortality rate in emergency laparotomies surgeries.
Time frame: 1 year
morbidity rate in emergency laparotomies surgeries.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2022.
- Background: PubMed 26615537Nag 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.
- Background: PubMed 22728205Saunders 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.
- Background: PubMed 17550623Rix 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.
- Background: PubMed 24179907Ahuja 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.
- Background: PubMed 24403619Mercer 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.
- Background: PubMed 12555290Neary 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.
- Background: PubMed 1959406Knaus 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.
- Background: PubMed 2567904Chang 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.
- Background: PubMed 30172358Kongkaewpaisan 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.
- Background: PubMed 28554491Peponis 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.
- Background: PubMed 31259871Vasileiou 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.
- Derived from this study: PubMed 40624475Montasser 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Emergencies, run by Assiut University.
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 2 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 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Doaa A. Mohamed (+201111834281, doaaellisy25@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: "through study completion, an average of 1 year".). 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 NCT05639920, which also lists 12 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 Dec 2022.