Comparative Analysis of APACHE II and P-POSSUM

Completed

• Conditions: External Causes of Morbidity and Mortality

• Registration Number: NCT02471612
• Lead Sponsor: Tata Main Hospital

Brief Summary

To compare APACHE II and P-POSSUM scoring system in emergency laparotomy.

Detailed Description

To compare APACHE II and P-POSSUM scoring system in predicting postoperative mortality in patients undergoing emergency laparotomy.

Study Timeline

• Study Start: 2013-12
• Primary Completion: 2014-11
• Study Completion: 2014-12
• Study First Submitted: 2015-06-09
• Study First Submitted QC: 2015-06-10
• Study First Posted: 2015-06-15
• Results First Submitted: 2015-12-20
• Status Verified: 2016-05
• Results First Submitted QC: 2016-05-17
• Results First Posted: 2016-06-27
• Last Update Submitted: 2019-10-06
• Last Update Posted: 2019-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 159

Inclusion Criteria

• All patients above 18 years of age undergoing emergency laparotomy at Tata Main Hospital form 01st December 2013 to 30th November 2014 will be included in the study.

Exclusion Criteria

• Patients willingly seeking referral to a different hospital

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Area Under the Receiver Operating Curve (ROC) as a Measure of the Accuracy of the APACHE II and P-POSSUM Scoring Systems to Predict Mortality	30 days	Participants will be followed for the duration of hospital stay (expected average of 30 days) and mortality was noted.All patients undergoing emergency laparotomy at Tata Main Hospital form 01st December 2013 to 30th November 2014 were included in the study. All patients were scored with APACHE II and P-POSSUM scoring systems on the day of surgery. Area under the curve (AUC) is used to measure the "size" of the prediction composed by the graphic display between the 'sensitivity' and the '1-specificity' relationship. AUC can range from 0.5 to 1.0 and a result of 1.0 indicates a perfect discriminatory ability. An AUC value \> 0.8 is considered good, a range between 0.60-0.80 is considered as moderate, and an AUC value \< 0.60 is regarded as poor. For APACHE-II, a cut off score of \>/=24 was determined; for P-POSSUM, a cut off score of \>/= 63 was determined.

Secondary Outcome Measures

Name	Time	Method
Length of Stay (LOS)	30 days	The mean duration of hospital stay or Length of Stay was recorded
Cardiac Morbidity (AMI or Arrhythmias Needing Treatment)	30 days	Number of patients noted to have Cardiac morbidity: Acute myocardial infarction (AMI) or arrhythmias needing treatment
Patients Needing Re-exploration	30 days	Number of patients needing return to the operation theater for surgery for the same pathology or any other complication arising out of the initial surgery
Need for Postoperative Ventilator Support	30 days	Number of patients needing post-operative ventilatory support
Need for Post Operative Inotropic Support	30 days	Number of patients needing post-operative inotropic support
Number of Participants With Acute Kidney Injury (AKI)	30 days	Acute Kidney Injury (AKI) was diagnosed based on the Kidney Disease: Improving Global Outcomes (KDIGO) Acute Kidney Injury Work Group (2012) guidelines; 1. Increase in Serum Creatinine (S. Cr) by ≥0.3 mg/dl (≥ 26.5 μmol/l) within 48 hours; OR; 2. Increase in S. Cr to ≥1.5 times baseline, which is known or presumed to have occurred within prior 7 days; OR; 3. Urine volume \<0.5 ml/kg/h for 6 hours

Trial Locations

Locations (1)

Tata Main Hospital; 🇮🇳 Jamshedpur, Jharkhand, India