- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02471612
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
Conditions
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
|
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.
Sponsor
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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