External Causes of Morbidity and MortalityNCT02471612

Comparative Analysis of APACHE II and P-POSSUM

An observational study of External Causes of Morbidity and Mortality, run by Tata Main Hospital at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To compare APACHE II and P-POSSUM scoring system in emergency laparotomy. Read more about this study

Who is it for?: Any age
Conditions the study is for: External Causes of Morbidity and Mortality
How many people: 159 participants
Where: 1 siteIndia
Study dates: Dec 2013to Dec 2014
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

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.

Who may be able to join

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.

Who cannot join

Patients willingly seeking referral to a different hospital

Trial locations and contacts

1 site in 1 country.

India1 site

Tata Main Hospital
Jamshedpur, Jharkhand, 831001

Other trials in India

About this study

Official title: 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.

Read the detailed description

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

Conditions: External Causes of Morbidity and Mortality

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 30 days

Secondary outcomes (6)

Length of Stay (LOS)
The mean duration of hospital stay or Length of Stay was recorded
Measured: 30 days
Need for Postoperative Ventilator Support
Number of patients needing post-operative ventilatory support
Measured: 30 days
Need for Post Operative Inotropic Support
Number of patients needing post-operative inotropic support
Measured: 30 days
Cardiac Morbidity (AMI or Arrhythmias Needing Treatment)
Number of patients noted to have Cardiac morbidity: Acute myocardial infarction (AMI) or arrhythmias needing treatment
Measured: 30 days
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
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
Measured: 30 days
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
Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2013Dec 2014

First posted15 Jun 2015 (estimated)
Study startDec 2013
Primary completionNov 2014
Study completionDec 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for External Causes of Morbidity and MortalityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 159 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02471612
Sponsor's protocol ID: 201-26104-132-108296
Status last verified: May 2016
First submitted: 9 Jun 2015
Last updated: 15 Oct 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

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.
PubMed 31531317

Study at a glance

From the registry record, last updated by the sponsor on 15 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparative Analysis of APACHE II and P-POSSUM Scoring Systems in Predicting Postoperative Mortality in Patients Undergoing Emergency Laparotomy
ClinicalTrials.gov ID: NCT02471612
Acronym / sponsor ID: 201-26104-132-108296
Conditions: External Causes of Morbidity and Mortality
Study type: Observational
Recruitment status: Completed
Enrolment: 159 participants (actual)
Lead sponsor: Tata Main HospitalUniversity, hospital or other
Study start: Dec 2013
Primary completion: Nov 2014 (actual)
Study completion: Dec 2014 (actual)
First posted: 15 Jun 2015 (estimated)
Results: Posted 27 Jun 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Observational model: Cohort
Time perspective: Retrospective

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
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.

Key inclusion criteria (1 listed)

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.

Key exclusion criteria (1 listed)

Patients willingly seeking referral to a different hospital

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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.

6 secondary outcomes

Length of Stay (LOS)
Time frame: 30 days
Need for Postoperative Ventilator Support
Time frame: 30 days
Need for Post Operative Inotropic Support
Time frame: 30 days
Cardiac Morbidity (AMI or Arrhythmias Needing Treatment)
Time frame: 30 days
Number of Participants With Acute Kidney Injury (AKI)
Time frame: 30 days
Patients Needing Re-exploration
Time frame: 30 days

Results and safety

Results posted to the registry on 27 Jun 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Patients Who Underwent Emergency Exploratory Laparotomy	159	157

Primary outcome: 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. Number (95% Confidence Interval). Unit: probability of accurate prediction

Measure	AUC Using APACHE II n = 157	AUC Using P-POSSUM n = 157
Value	0.965 (0.928 to 1.000)	0.989 (0.974 to 1.000)

AUC Using APACHE II vs AUC Using P-POSSUM: p = 0.665, McNemar

Population analysed: All patients undergoing emergency laparotomy at Tata Main Hospital form December 2013 to November 2014 were scored with APACHE II \& P-POSSUM scoring systems on the day of surgery. The patients were followed up till at least 30 days after discharge or death (during admission or within 30 days after discharge).

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: The patients were followed up for the duration of admission and till at least 30 days after discharge or death (whichever was earlier).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
APACHE-2 Scoring	0 of 157 (0%)	0 of 157 (0%)	Not reported
P-POSSUM	0 of 157 (0%)	0 of 157 (0%)	Not reported

Limitations and caveats (from the sponsor): Observational study. So no specific adverse effect because of the study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 31531317Nag 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.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ankur Dembla, DA principal investigator

Tata Main Hospital, Jamshedpur, India

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of External Causes of Morbidity and Mortality, run by Tata Main Hospital at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02471612, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2019.