Comparative Analysis of APACHE II and P-POSSUM

October 6, 2019 updated by: Dr.Deb Sanjay Nag, Tata Main Hospital

Comparative Analysis of APACHE II and P-POSSUM Scoring Systems in Predicting Postoperative Mortality in Patients Undergoing Emergency Laparotomy

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

Study Overview

Status

Completed

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

159

Contacts and Locations

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

Study Locations

    • Jharkhand
      • Jamshedpur, Jharkhand, India, 831001
        • Tata Main Hospital

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients undergoing emergency laparotomy at Tata Main Hospital form 01st December 2013 to 30th November 2014 will be included in the study. All patients will be scored with APACHE II and P-POSSUM scoring systems on the day of surgery.The patients will be followed up till discharge, death or 30 days postoperatively.

Description

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 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 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.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of Stay (LOS)
Time Frame: 30 days
The mean duration of hospital stay or Length of Stay was recorded
30 days
Need for Postoperative Ventilator Support
Time Frame: 30 days
Number of patients needing post-operative ventilatory support
30 days
Need for Post Operative Inotropic Support
Time Frame: 30 days
Number of patients needing post-operative inotropic support
30 days
Cardiac Morbidity (AMI or Arrhythmias Needing Treatment)
Time Frame: 30 days
Number of patients noted to have Cardiac morbidity: Acute myocardial infarction (AMI) or arrhythmias needing treatment
30 days
Number of Participants With Acute Kidney Injury (AKI)
Time Frame: 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
30 days
Patients Needing Re-exploration
Time Frame: 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
30 days

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Ankur Dembla, DA, Tata Main Hospital, Jamshedpur, India

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.

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

December 1, 2013

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

June 9, 2015

First Submitted That Met QC Criteria

June 10, 2015

First Posted (Estimate)

June 15, 2015

Study Record Updates

Last Update Posted (Actual)

October 15, 2019

Last Update Submitted That Met QC Criteria

October 6, 2019

Last Verified

May 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 201-26104-132-108296

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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