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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02471612
Other study ID # 201-26104-132-108296
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 2013
Est. completion date December 2014

Study information

Verified date May 2016
Source Tata Main Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


Description:

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


Recruitment information / eligibility

Status Completed
Enrollment 159
Est. completion date December 2014
Est. primary completion date November 2014
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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


Related Conditions & MeSH terms

  • External Causes of Morbidity and Mortality

Locations

Country Name City State
India Tata Main Hospital Jamshedpur Jharkhand

Sponsors (1)

Lead Sponsor Collaborator
Tata Main Hospital

Country where clinical trial is conducted

India, 

References & Publications (1)

Nag DS, Dembla A, Mahanty PR, Kant S, Chatterjee A, Samaddar DP, Chugh P. Comparative analysis of APACHE-II and P-POSSUM scoring systems in predicting postoperative mortality in patients undergoing emergency laparotomy. World J Clin Cases. 2019 Aug 26;7(1 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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 Length of Stay (LOS) The mean duration of hospital stay or Length of Stay was recorded 30 days
Secondary Need for Postoperative Ventilator Support Number of patients needing post-operative ventilatory support 30 days
Secondary Need for Post Operative Inotropic Support Number of patients needing post-operative inotropic support 30 days
Secondary Cardiac Morbidity (AMI or Arrhythmias Needing Treatment) Number of patients noted to have Cardiac morbidity: Acute myocardial infarction (AMI) or arrhythmias needing treatment 30 days
Secondary Number of Participants With Acute Kidney Injury (AKI) Acute Kidney Injury (AKI) was diagnosed based on the Kidney Disease: Improving Global Outcomes (KDIGO) Acute Kidney Injury Work Group (2012) guidelines
Increase in Serum Creatinine (S. Cr) by =0.3 mg/dl (= 26.5 µmol/l) within 48 hours; OR
Increase in S. Cr to =1.5 times baseline, which is known or presumed to have occurred within prior 7 days; OR
Urine volume <0.5 ml/kg/h for 6 hours
30 days
Secondary Patients Needing Re-exploration 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
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