External Causes of Morbidity and Mortality
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Tata Main Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Need for Postoperative Ventilator Support | 30 days | Number of patients needing post-operative ventilatory support |
| Need for Post Operative Inotropic Support | 30 days | Number of patients needing post-operative inotropic support |
| Length of Stay (LOS) | 30 days | The mean duration of hospital stay or Length of Stay was recorded |
| Number of Participants With Acute Kidney Injury (AKI) | 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 |
| Patients Needing Re-exploration | 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 |
| Cardiac Morbidity (AMI or Arrhythmias Needing Treatment) | 30 days | Number of patients noted to have Cardiac morbidity: Acute myocardial infarction (AMI) or arrhythmias needing treatment |
Countries
India
Participant flow
Recruitment details
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
Participants by arm
| Arm | Count |
|---|---|
| Emergency 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 APACHE-2 Score & P-POSSUM Score | 157 |
| Total | 157 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
Baseline characteristics
| Characteristic | Emergency Laparotomy |
|---|---|
| Age, Customized 18- 20 years | 11 participants |
| Age, Customized 21-40 years | 45 participants |
| Age, Customized 41-60 years | 60 participants |
| Age, Customized 61-80 years | 38 participants |
| Age, Customized > 80years | 3 participants |
| Region of Enrollment India | 157 participants |
| Sex: Female, Male Female | 58 Participants |
| Sex: Female, Male Male | 99 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 157 | 0 / 157 |
| serious Total, serious adverse events | 0 / 157 | 0 / 157 |
Outcome results
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.
Time frame: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AUC Using APACHE II | 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 |
| AUC Using P-POSSUM | 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 | 0.989 probability of accurate prediction |
Comparison: 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.p-value: 0.665McNemar
Secondary
Cardiac Morbidity (AMI or Arrhythmias Needing Treatment)
Number of patients noted to have Cardiac morbidity: Acute myocardial infarction (AMI) or arrhythmias needing treatment
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AUC Using APACHE II | Cardiac Morbidity (AMI or Arrhythmias Needing Treatment) | 1 participants |
| AUC Using P-POSSUM | Cardiac Morbidity (AMI or Arrhythmias Needing Treatment) | 7 participants |
Secondary
Length of Stay (LOS)
The mean duration of hospital stay or Length of Stay was recorded
Time frame: 30 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AUC Using APACHE II | Length of Stay (LOS) | Surviving Patients | 9.36 Days | Standard Deviation 8.04 |
| AUC Using APACHE II | Length of Stay (LOS) | Patients who Died | 14.91 Days | Standard Deviation 15.43 |
Secondary
Need for Post Operative Inotropic Support
Number of patients needing post-operative inotropic support
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AUC Using APACHE II | Need for Post Operative Inotropic Support | 25 participants |
| AUC Using P-POSSUM | Need for Post Operative Inotropic Support | 23 participants |
Secondary
Need for Postoperative Ventilator Support
Number of patients needing post-operative ventilatory support
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AUC Using APACHE II | Need for Postoperative Ventilator Support | 40 participants |
| AUC Using P-POSSUM | Need for Postoperative Ventilator Support | 23 participants |
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 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
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AUC Using APACHE II | Number of Participants With Acute Kidney Injury (AKI) | 14 participants |
| AUC Using P-POSSUM | Number of Participants With Acute Kidney Injury (AKI) | 18 participants |
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
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AUC Using APACHE II | Patients Needing Re-exploration | 2 participants |
| AUC Using P-POSSUM | Patients Needing Re-exploration | 2 participants |