| CTRI Number |
CTRI/2021/07/034504 [Registered on: 01/07/2021] Trial Registered Prospectively |
| Last Modified On: |
30/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To determine the applicability of Emergency Surgery Score (ESS) in predicting post-operative complications in patients undergoing emergency laparotomy for non trauma cause |
|
Scientific Title of Study
|
Validation of Emergency Surgery Score (ESS) in predicting post-operative course 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 |
Srishti Bhowmik |
| Designation |
Post Graduate student |
| Affiliation |
MAULANA AZAD MEDICAL COLLEGE |
| Address |
Department of Surgery, 2nd floor, B L Taneja Block, Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi
Central
DELHI
110002
India |
| Phone |
|
| Fax |
|
| Email |
surgery.srishtibhowmik.2020@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chandra Bhushan Singh |
| Designation |
HOD Surgery |
| Affiliation |
MAULANA AZAD MEDICAL COLLEGE |
| Address |
Department of Surgery, 2nd floor, B L Taneja Block, Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi
Central
DELHI
110002
India |
| Phone |
|
| Fax |
|
| Email |
drchandrabhushansingh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chandra Bhushan Singh |
| Designation |
HOD Surgery |
| Affiliation |
MAULANA AZAD MEDICAL COLLEGE |
| Address |
Department of Surgery, 2nd floor, B L Taneja Block, Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi
Central
DELHI
110002
India |
| Phone |
|
| Fax |
|
| Email |
drchandrabhushansingh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lok Nayak Hospital, New Delhi |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
2, Bahadur Shah Zafar Marg, New Delhi-110002 |
| Type of Sponsor |
Government medical college |
|
|
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 Chandra Bhushan Singh |
Lok Nayak Hospital |
Lok Nayak Hospital, Bahadur Shah Zafar Marg, near Delhi Gate, New Delhi - 110002
Central
DELHI |
011-23236000
drchandrabhushansingh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee, Room no 306B,Maulana Azad Medical college |
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 |
99.00 Year(s) |
| Gender |
Both |
| Details |
All cases aged 18 years and above undergoing emergency laparotomy |
|
| ExclusionCriteria |
| Details |
Patients of trauma requiring laparotomy
Pregnancy |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of mortality within 30 days of procedure |
POD 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of one or more of the following within 30 days of procedure- postoperative ICU admission, Postoperative complications, Reoperation, Readmission |
POD 30 |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
01/07/2021 |
| 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
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is prospective observational study to verify efficacy of Emergency Surgery Score (ESS) in predicting any adverse event during the post-operative course of patients undergoing emergency laparotomy for non-trauma causes in Lok Nayak Hospital. Primary outcome will be mortality incidence within 30 days of procedure. Secondary outcomes will include post-operative ICU admission, post-operative complications, re-operation and readmission within 30 day period of procedure. |