NCT02471612

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
159

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 15, 2015

Completed
1 year until next milestone

Results Posted

Study results publicly available

June 27, 2016

Completed
Last Updated

October 15, 2019

Status Verified

May 1, 2016

Enrollment Period

11 months

First QC Date

June 9, 2015

Results QC Date

December 20, 2015

Last Update Submit

October 6, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Length of Stay (LOS)

    30 days

  • Need for Postoperative Ventilator Support

    30 days

  • Need for Post Operative Inotropic Support

    30 days

  • Cardiac Morbidity (AMI or Arrhythmias Needing Treatment)

    30 days

  • Number of Participants With Acute Kidney Injury (AKI)

    30 days

  • +1 more secondary outcomes

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • Patients willingly seeking referral to a different hospital

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tata Main Hospital

Jamshedpur, Jharkhand, 831001, India

Location

Related 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(16):2227-2237. doi: 10.12998/wjcc.v7.i16.2227.

Limitations and Caveats

Observational study. So no specific adverse effect because of the study.

Results Point of Contact

Title
Dr.Deb Sanjay Nag
Organization
Tata Main Hospital

Study Officials

  • Ankur Dembla, DA

    Tata Main Hospital, Jamshedpur, India

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Specialist

Study Record Dates

First Submitted

June 9, 2015

First Posted

June 15, 2015

Study Start

December 1, 2013

Primary Completion

November 1, 2014

Study Completion

December 1, 2014

Last Updated

October 15, 2019

Results First Posted

June 27, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations