| CTRI Number |
CTRI/2022/05/042365 [Registered on: 04/05/2022] Trial Registered Prospectively |
| Last Modified On: |
29/04/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Research to compare a score called P-POSSUM at admission and before operation for prediction of possibility of death after operation |
|
Scientific Title of Study
|
Comparative analysis of P-POSSUM score at admission and pre-operatively mortality in patients undergoing emergency laparotomy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vivek Kumar Roy |
| Designation |
Assistant Professor |
| Affiliation |
Indira Gandhi Institute of Medical Sciences (IGIMS), Patna |
| Address |
Department of Surgery, Indira Gandhi Institute of Medical Sciences, Sheikhpura, Patna, PIN 800014
Patna
BIHAR
800014
India |
| Phone |
9801716613 |
| Fax |
|
| Email |
roykanu23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vivek Kumar Roy |
| Designation |
Assistant Professor |
| Affiliation |
Indira Gandhi Institute of Medical Sciences (IGIMS), Patna |
| Address |
Department of Surgery, Indira Gandhi Institute of Medical Sciences, Sheikhpura, Patna, PIN 800014
BIHAR
800014
India |
| Phone |
9801716613 |
| Fax |
|
| Email |
roykanu23@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vivek Kumar Roy |
| Designation |
Assistant Professor |
| Affiliation |
Indira Gandhi Institute of Medical Sciences (IGIMS), Patna |
| Address |
Department of Surgery, Indira Gandhi Institute of Medical Sciences, Sheikhpura, Patna, PIN 800014
BIHAR
800014
India |
| Phone |
9801716613 |
| Fax |
|
| Email |
roykanu23@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indira Gandhi Institute of Medical sciences (IGIMS), Patna |
|
|
Primary Sponsor
|
| Name |
Dr Vivek Kumar Roy |
| Address |
Department of General Surgery, IGIMS, Patna 800014 |
| Type of Sponsor |
Other [Individual (self) investigator funded] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vivek Kumar Roy |
Department of General Surgery, IGIMS, Patna |
Department of Surgery, Indira Gandhi Institute of Medical Sciences, Sheikhpura, Patna, PIN 800014
Patna
BIHAR |
9801716613
roykanu23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, IGIMS, Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All patients of acute abdomen admitted under General Surgery requiring emergency laparatomy |
|
| ExclusionCriteria |
| Details |
1. Age <18 years
2. Daycare surgery
3. Routine surgery
4. Followâ€up criteria cannot be fulfilled, i.e., patient
absconds, and contact cannot be done. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| rate of death (mortality) among the participants |
to be assessed daily up to 30 days after the procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| rate of surgical site infection and pain |
to be assessed daily up to 30 days after the procedure |
|
|
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)
|
06/05/2022 |
| 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="0"
Days="0" |
|
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)?
Response - NO
|
|
Brief Summary
|
HYPOTHESIS To document the accuracy of P-POSSOM score on predicting the mortality and morbidity. To establish that post resuscitation score is more accurate than admission score. AIMS AND OBJECTIVES 1. To evaluate the predictive value of the score in the patients in our setup 2. To evaluate which timing of scoring is more accurate (at the time of admission or pre-operatively after initial resuscitation). MATERIALS AND METHODS This will be a prospective crossâ€sectional study and will include all patients who are operated for emergency laparotomy >18 years of age over a period of one year in the department of general surgical . Inclusion criteria All patients of acute abdomen admitted under General Surgery requiring emergency laparatomy. The exclusion criteria of this study are as follows: 1. Age <18 years 2. Daycare surgery 3. Routine surgery 4. Followâ€up criteria cannot be fulfilled, i.e., patient absconds, and contact cannot be done. Methodology Patient of acute pain abdomen admitted for emergency laparatomy. Informed consent. Admission Physiological P-POSSOM Score. Resuscitate. Post resuscitation Physiological P-POSSOM score. Laparotomy. Operative P-POSSOM score. Calculate the P-POSSOM for Admission and Pre-operative. Follow-up 30 days post operative . Any morbidity or mortality will be end point. |