| CTRI Number |
CTRI/2024/09/074317 [Registered on: 25/09/2024] Trial Registered Prospectively |
| Last Modified On: |
17/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Decribing Global 30 days post operative mortality rates for patients undergoing trauma laprotomy
|
|
Scientific Title of Study
|
An observational study assessing the global variation in patient characteristics, management, and outcomes in those undergoing trauma laparotomy |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Tej Prakash Sinha |
| Designation |
Additional Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Department of Emergency Medicine AIIMS New Delhi
New Delhi
DELHI
110029
India |
| Phone |
8518881749 |
| Fax |
|
| Email |
drsinha123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tej Prakash Sinha |
| Designation |
Additional Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Department of Emergency Medicine AIIMS New Delhi
New Delhi
DELHI
110029
India |
| Phone |
8518881749 |
| Fax |
|
| Email |
drsinha123@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tej Prakash Sinha |
| Designation |
Additional Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Department of Emergency Medicine AIIMS New Delhi
New Delhi
DELHI
110029
India |
| Phone |
8518881749 |
| Fax |
|
| Email |
drsinha123@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
University of Cambridge |
| Address |
Department of Engineering
University of Cambridge |
| Type of Sponsor |
Government funding agency |
|
|
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 TEJ PRAKASH SINHA |
JPNATC, AIIMS,NEW DELHI |
RED AREA, JAY PRAKASH NARAYAN APEX TRAUMA CENTRE, AIIMS,NEW DELHI
New Delhi
DELHI |
8518881749
drsinha123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS, NEW DELHI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: S318||Open wound of other parts of abdomen, lower back and pelvis, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
patients of all ages who present to hospital with a blunt or penetrating injury and undergo a trauma laparotomy within 5 days of presentation to the treating centre (day 0 being timeof presentation). A patient will be included for final analysis if >70% of the data points required have been recorded. |
|
| ExclusionCriteria |
| Details |
Patients undergoing a laparotomy ≥ 5 days (i.e. 120 hours) since presentation to the treating centre.Any relook laparotomy, including transfers from another centre for further and / or definitive surgery.Any laparoscopic (including laparoscopic converted to open), robotic, or image-guided procedures.Patients who have been recently discharged from any hospital (including for non-trauma related admissions) and have represented within 30 days of discharge. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| global patient, injury, and surgical factors for patients undergoing trauma laparotomy |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Determining the global pre-, peri-, & post-operative care process for patients undergoing trauma laparotomy |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="3000"
Sample Size from India="300"
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)
|
30/09/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Trauma accounts for approximately 9% of all global deaths and contributes the greatest loss of disability-adjusted life-years for adolescents and young adults worldwide . In the context of global abdominal trauma, both blunt and penetrating, the trauma laparotomy is the most commonly performed operation; it can be used both as a means to access identified injuries to organs within the abdomen and pelvis, such as life-threatening bleeding (from vessels or solid organs) or contamination (from hollow viscus injuries), or for exploratory diagnostic reasons, where cross-sectional imaging may not be easily feasible or available. Whilst mortality rates following a trauma laparotomy are substantial, ranging between 8-40% (3–8), in recent years the role of damage control resuscitation has transformed trauma care, with significant reduction in mortality and morbidity to trauma patients being observed .However, the standard of care and variation in practice occurring globally for patients undergoing a trauma laparotomy remain relatively unknown.Variation likely exists worldwide in the management and outcomes of patients following trauma laparotomy however at present its limited data exists. Hence, this study is to evaluate both patient and injury factors for those undergoing trauma laparotomy, their clinical management, and post-operative outcomes.Data will be collected through access to patient records only at each centre, performed by members of the local study team. The patient will not be contacted directly in any during their inpatient stay or after the study. The study is observational and no direct involvement in patient care will occur. Data will be collected either directly onto the REDCap cloud (see Data Management) or recorded temporarily onto a hard copy Data Collection Form, which will then be stored securely before the data then is uploaded to the REDCap cloud (with the forms subsequently being destroyed safely).The mean and standard deviation will be reported for all normally distributed variables and the median and interquartile range for non-normally distributed variables. Participating centres will be stratified based on their country into groups based on their Human Development Index (HDI) rank, with 30-day mortality then reported for each HDI group and compared using the Pearson chi squared test. |