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CTRI Number  CTRI/2020/06/025678 [Registered on: 08/06/2020] Trial Registered Prospectively
Last Modified On: 03/06/2020
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   logistic regression study design 
Study Design  Other 
Public Title of Study   To Compare between two scoring system - POSSUM AND PORTSMOUTH POSSUM scoring for surgical assessment in predicting mortality(death) and morbididty(severely diseased) in patients undergoing emergency abdominal surgeries. 
Scientific Title of Study   POSSUM AND PORTSMOUTH POSSUM scoring for surgical assessment in predicting mortality and morbidity in emergency abdominal surgeries. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nithya Shekar 
Designation  Post graduate student - General Surgery  
Affiliation  KALINGA INSTITUTE OF MEDICAL SCIENCES 
Address  Department of General Surgery first floor, PBMH, Kims.

Khordha
ORISSA
751024
India 
Phone  9731340423  
Fax    
Email  nithyashekar1810@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR PK DEBATA 
Designation  Professor in department of General Surgery 
Affiliation  KALINGA INSTITUTE OF MEDICAL SCIENCES 
Address  Department of General Surgery, First floor. PBMH , Kims.

Khordha
ORISSA
751024
India 
Phone  9437078964  
Fax    
Email  pk_debata@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  DR PK DEBATA 
Designation  Professor - General Surgery  
Affiliation  KALINGA INSTITUTE OF MEDICAL SCIENCES 
Address  Department of General Surgery. First floor , PBMH, KIMS

Khordha
ORISSA
751024
India 
Phone  9437078964  
Fax    
Email  pk_debata@yahoo.com  
 
Source of Monetary or Material Support  
Nithya Shekar Department of General Surgery, Kims 
 
Primary Sponsor  
Name  Nithya Shekar 
Address  Department of General Surgery,First floor , PBMH, KIMS. Bhubaneswar, Odisha 751024  
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
NITHYA SHEKAR   Kalinga Institute of medical sciences.  Kalinga Institute of medical sciences, Department of General Surgery, First floor Campus 5 , KIIT Road Patia, Bhubaneswar , Odisha 751024
Khordha
ORISSA 
9731340423

nithyashekar1810@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Y999||Unspecified external cause status,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1)All patients undergoing emergency abdominal surgeries at our hospital, KIMS .

2)The patients who will be willing to comply with the study group.
 
 
ExclusionCriteria 
Details  1) Patients aged 18 years or less.
2) In those whom follow up period criteria will not be met
3) Patients with significant immunosuppression
- HIV/HBsAg/HCV positive
- Those on immunosuppressive drugs
- Those on anti-cancer chemotherapeutic drugs 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To compare the two scoring systems POSSUM and P-POSSUM and evaluate for which offers more accurate results.
-To see which are the factors causing more mortality and morbidity. 
2 years 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the two scoring systems POSSUM and P-POSSUM and evaluate for which offers more accurate results.
-To see whick are the factors causing more mortality and morbidity. 
2 YEARS 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/07/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="11"
Days="29" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

POSSUM AND PORTSMOUTH POSSUM SCORING FOR SURGICAL ASSESSMENT IN PREDICTING MORTALITY AND MORBIDITY IN EMERGENCY ABDOMINAL SURGERIES

  INTRODUCTION:

 

Surgery is considered one of the essential healthcare services. As many demographic parameters have shifted over the years, there has been an increase in emergency surgeries in India. This increase is attributed to population growth.

 

Crude morbidity and mortality rates are limited indicators of quality of care, and can be misleading when the results of emergency surgery are compared between different units and hospitals. Scoring systems that group patients based on the severity of illness before treatment can allow a meaningful analysis of morbidity and mortality rates. Risk-adjusted comparisons can then be made between surgeons and hospitals.

 

The Physiological Operative Severity Score for the enumeration of Mortality and morbidity {POSSUM} is widely used to predict morbidity and mortality in a variety of surgical settings, and provides a tool for risk adjustment and comparison.

Risk scoring helps us quantify the prospects of adverse outcome in a patient. 

 

POSSUM as well as, Portsmouth-Physiological and Operative Severity Score for the Enumeration of Mortality and Morbidity (P-POSSUM) , both over the world have proved itself as a worthy scoring system and the present study is being done to evaluate the feasibility of POSSUM SCORING SYSTEM and  PORTSMOUTH-POSSUM SCORING SYSTEM as a risk scoring system as a tool in efficacious prediction of mortality and morbidity in EMERGENCY ABDOMINAL SURGERIES in our demographic profile and which system is better applicable

 The Physiological and Operative Severity Score for enumeration of Mortality and morbidity {POSSUM}

And

PORTSMOUTH- POSSUM.

have been devised specifically for prediction in surgical patients. It uses 12 physiological and 6 operative variables to give a calculated risk of morbidity and death. POSSUM was intended to be used in Evaluation of Possum Scoring In Patients Undergoing Emergency surgeries .

The Physiological variables being

1. Age

2. Cardiac signs

3. Chest Xray (cardiac changes) , Chest Xray (respiratory changes)

4. Systolic B.P

5. Pulse rate (bpm)

6. Glasgow coma scale

7. Hemoglobin

8. WBC Count

9. Blood Urea(mmol/l)

10. Serum Sodium(mmol/l), Serum Potassium(mmol/l)

11. ECG Changes

12. Respiratory history

 

OPERATIVE SCORING

1. Number of operations within 30 days.

2. Blood loss per operation (ml)

3. Peritoneal contamination.

4. Presence of malignancy.

5. Mode of surgery.

 

 

The POSSUM mortality equation as published by Copeland et al is in

 {R/(1-R)}= -7.04 + (0.13 x physiological score) + (0.16 x operative score),

where R is the predicted risk of mortality and is in the standard form of equation as produced by logistical regression.

 

The PORTSMOUTH-POSSUM mortality equation as published by Whiteley et al is in

 

Loge[R/1-R]=(0.1692xPhysiologicalscore)+(0.155xOperative score)-9.065.

where R = risk of mortality.

 

There is much confusion about the way POSSUM scores are analyzed. The result of the POSSUM data set is physiology score of 12-88 and operative score of 6- 44. Although the higher the overall POSSUM score, the greater the risk of morbidity and mortality, individual scores do not reflect the percentage risk. These two scores are most useful as a part of a regression equation that is used to produce a percentage risk. The regression equation includes a constant number and weighted scores for physiology and operative risk {(R/1-R) = -7.04 + (0.13xPS) + (0.16xOS)}. A different constant and weighted value is needed to predict morbidity and mortality.

 

2 ) AIMS:

 

PRIMARY AIM:

Using POSSUM AND P-POSSUM SCORING SYSTEM  to predict mortality and morbidity in patients undergoing emergency abdominal surgeries

 

SECONDARY AIM:

To evaluate the strength of P-POSSUM SCORING SYSTEM in predicting mortality and morbidity.

  

 

 

 

 

 

3) MATERIAL AND METHODS:

3.1) STUDY DESIGN: Prospective observational study design  from September 2019 to August 2021  in  KIMS, BBSR.

 

3.2) TIME AND DURATION OF STUDY:  2 years from July 2020 to July 2022

 

 

 

 

 3.4) Inclusion criteria:

1) All patients undergoing emergency abdominal surgeries

 at our hospital, KIMS .

 

2)The patients who will be willing to comply with the

   study group.

 

 

 

3.5) Exclusion criteria:

1) Patients aged 18 years or less.

2) In those whom follow up period criteria will not be met

3) Patients with significant immunosuppression

     -HIV/HBsAg/HCV positive

     -Those on immunosuppressive drugs

     -Those on anti-cancer chemotherapeutic drugs

 

 

 3.7) Source of data:

Patients who are admitted in the  Department of General surgery, Kalinga Institute of Medical Sciences, Bhubaneswar for emergency abdominal surgeries during the period September 2019 to August 2021.

 

 

3.8) SAMPLE SIZE  : 150 patients


 


 


 


 
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