Trial Outcomes & Findings for Comparative Analysis of APACHE II and P-POSSUM (NCT NCT02471612)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

159 participants

Primary outcome timeframe

30 days

Results posted on

2019-10-15

Participant Flow

All who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, India who met the inclusion criteria were included in the study

Participant milestones

Participant milestones
Measure	All Patients Who Underwent Emergency Exploratory Laparotomy All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria were scored using the P-POSSUM Score APACHE-II
Overall Study STARTED	159
Overall Study COMPLETED	157
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	All Patients Who Underwent Emergency Exploratory Laparotomy All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria were scored using the P-POSSUM Score APACHE-II
Overall Study Lost to Follow-up	2

Baseline Characteristics

Comparative Analysis of APACHE II and P-POSSUM

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Emergency Laparotomy n=157 Participants All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria were scored using the APACHE-2 Score \& P-POSSUM Score
Age, Customized 18- 20 years	11 participants n=99 Participants
Age, Customized 21-40 years	45 participants n=99 Participants
Age, Customized 41-60 years	60 participants n=99 Participants
Age, Customized 61-80 years	38 participants n=99 Participants
Age, Customized > 80years	3 participants n=99 Participants
Sex: Female, Male Female	58 Participants n=99 Participants
Sex: Female, Male Male	99 Participants n=99 Participants
Region of Enrollment India	157 participants n=99 Participants

PRIMARY outcome

Timeframe: 30 days

Population: 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).

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.

Outcome measures

Outcome measures
Measure	AUC Using APACHE II n=157 Participants 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 on the day of surgery.	AUC Using P-POSSUM n=157 Participants 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 P-POSSUM on the day of surgery.
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	0.965 probability of accurate prediction Interval 0.928 to 1.0	0.989 probability of accurate prediction Interval 0.974 to 1.0

SECONDARY outcome

Timeframe: 30 days

The mean duration of hospital stay or Length of Stay was recorded

Outcome measures

Outcome measures
Measure	AUC Using APACHE II n=157 Participants 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 on the day of surgery.	AUC Using P-POSSUM 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 P-POSSUM on the day of surgery.
Length of Stay (LOS) Surviving Patients	9.36 Days Standard Deviation 8.04	—
Length of Stay (LOS) Patients who Died	14.91 Days Standard Deviation 15.43	—

SECONDARY outcome

Timeframe: 30 days

Number of patients needing post-operative ventilatory support

Outcome measures

Outcome measures
Measure	AUC Using APACHE II n=134 Participants 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 on the day of surgery.	AUC Using P-POSSUM n=23 Participants 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 P-POSSUM on the day of surgery.
Need for Postoperative Ventilator Support	40 participants	23 participants

SECONDARY outcome

Timeframe: 30 days

Number of patients needing post-operative inotropic support

Outcome measures

Outcome measures
Measure	AUC Using APACHE II n=134 Participants 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 on the day of surgery.	AUC Using P-POSSUM n=23 Participants 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 P-POSSUM on the day of surgery.
Need for Post Operative Inotropic Support	25 participants	23 participants

SECONDARY outcome

Timeframe: 30 days

Number of patients noted to have Cardiac morbidity: Acute myocardial infarction (AMI) or arrhythmias needing treatment

Outcome measures

Outcome measures
Measure	AUC Using APACHE II n=134 Participants 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 on the day of surgery.	AUC Using P-POSSUM n=23 Participants 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 P-POSSUM on the day of surgery.
Cardiac Morbidity (AMI or Arrhythmias Needing Treatment)	1 participants	7 participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	AUC Using APACHE II n=134 Participants 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 on the day of surgery.	AUC Using P-POSSUM n=23 Participants 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 P-POSSUM on the day of surgery.
Number of Participants With Acute Kidney Injury (AKI)	14 participants	18 participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	AUC Using APACHE II n=134 Participants 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 on the day of surgery.	AUC Using P-POSSUM n=23 Participants 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 P-POSSUM on the day of surgery.
Patients Needing Re-exploration	2 participants	2 participants

Adverse Events

APACHE-2 Scoring

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

P-POSSUM

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr.Deb Sanjay Nag

Tata Main Hospital

Phone: +91-7763807101

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place