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

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05639920
Collaborator
(none)
138
13

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Combination Product: Scoreing

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

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
138 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Validation of Emergency Surgery Score (ESS) as Outcome Prediction Score in Egyptian Patients Undergoing Emergency Laparotomy
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Feb 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Group A

Combination Product: Scoreing
Validation of Emergency surgery score in predicting mortality and mortality in Egyptian patients undergoing Emergency laparotomy

Outcome Measures

Primary Outcome Measures

  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 ["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.

Secondary Outcome Measures

  1. mortality rate in emergency laparotomies surgeries. [1 year]

    case fatality rate in emergency laparotomies surgeries.

  2. morbidity rate in emergency laparotomies surgeries. [1 year]

    incidence of surgical site infection

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Doaa Ahmed Mohamed, Principal investigator, Assiut University
ClinicalTrials.gov Identifier:
NCT05639920
Other Study ID Numbers:
  • Emergency surgery score
First Posted:
Dec 7, 2022
Last Update Posted:
Dec 7, 2022
Last Verified:
Dec 1, 2022
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 7, 2022