Validation of Emergency Surgery Score (ESS) in Egyptian Patients Undergoing Emergency Laparotomy

December 3, 2022 updated by: Doaa Ahmed Mohamed, Assiut University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

138

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group A
Combination product: Scoreing
Validation of Emergency surgery score in predicting mortality and mortality in Egyptian patients undergoing Emergency laparotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
"through study completion, an average of 1 year".

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mortality rate in emergency laparotomies surgeries.
Time Frame: 1 year
case fatality rate in emergency laparotomies surgeries.
1 year
morbidity rate in emergency laparotomies surgeries.
Time Frame: 1 year
incidence of surgical site infection
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2023

Primary Completion (Anticipated)

January 1, 2024

Study Completion (Anticipated)

February 1, 2024

Study Registration Dates

First Submitted

October 26, 2021

First Submitted That Met QC Criteria

December 3, 2022

First Posted (Estimate)

December 7, 2022

Study Record Updates

Last Update Posted (Estimate)

December 7, 2022

Last Update Submitted That Met QC Criteria

December 3, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Emergency surgery score

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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