| CTRI Number |
CTRI/2024/05/068008 [Registered on: 28/05/2024] Trial Registered Prospectively |
| Last Modified On: |
27/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Predicting hip surgery complications in Indian elderly patients using a scoring system. |
|
Scientific Title of Study
|
Prediction of Morbidity and Mortality in Indian elderly patients undergoing hip surgery using American College Of Surgeons National Surgical Quality Improvement Programme (ACSNSQIP) |
| 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 Shivangi Sinha |
| Designation |
Post Graduate Student |
| Affiliation |
Kalinga Institute Of Medical Sciences |
| Address |
Department Of Anaesthesiology, Pradyumna Bal Memorial Hospital,Kalinga Institute Of Medical Sciences, Bhubaneswar
Khordha
ORISSA
751024
India |
| Phone |
7325930068 |
| Fax |
|
| Email |
2387008@kims.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjaya Kumar Behera |
| Designation |
Associate Professor |
| Affiliation |
Kalinga Institute Of Medical Sciences |
| Address |
Department Of Anaesthesiology, Pradyumna Bal Memorial Hospital,Kalinga Institute Of Medical Sciences, Bhubaneswar
Khordha
ORISSA
751024
India |
| Phone |
9778098186 |
| Fax |
|
| Email |
sanjayakumar.behera@kims.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjaya Kumar Behera |
| Designation |
Associate Professor |
| Affiliation |
Kalinga Institute Of Medical Sciences |
| Address |
Department Of Anaesthesiology, Pradyumna Bal Memorial Hospital,Kalinga Institute Of Medical Sciences, Bhubaneswar
Khordha
ORISSA
751024
India |
| Phone |
9778098186 |
| Fax |
|
| Email |
sanjayakumar.behera@kims.ac.in |
|
|
Source of Monetary or Material Support
|
| Kalinga Institute Of Medical Sciences,Patia, Bhubaneswar, Khordha, Odisha,India-751024 |
|
|
Primary Sponsor
|
| Name |
Dr Shivangi Sinha |
| Address |
Department Of Anaesthesiology, Pradyumna Bal Memorial Hospital,Kalinga Institute Of Medical Sciences, Bhubaneswar |
| Type of Sponsor |
Other [Self] |
|
|
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 Shivangi Sinha |
Kalinga Institute Of Medical Sciences |
Department Of Anaesthesiology, 3rd floor, PBMH, KIMS, Patia, Bhubaneswar
Khordha
ORISSA |
7325930068
2387008@kims.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Kalinga Institute of Medical Sciences |
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
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
95.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients age 60 years and above undergoing hip fracture surgeries.
2.American Society of Anesthesiologists (ASA) physical status I and II and III.
|
|
| ExclusionCriteria |
| Details |
1.Patients below 60 years of age.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 30 Days actual mortality rate compared to the 30 days predicted mortality rate according to the scoring system. |
T0-Preoperatively
T1-30 Days after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 30 Days actual complications rate compared to the 30 days predicted complication rate according to the scoring system. |
T0-Preoperatively
T1-30 days after surgery |
|
|
Target Sample Size
|
Total Sample Size="300"
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)
|
10/06/2024 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Hip fractures in the elderly population is associated with significant morbidity and mortality. Preoperative assessment can identify predictors for early mortality following hip fractures. The ACS-NSQIP was derived and validated to estimate risk of complications and can also suggest any intervention if required. Thus, we suggest this will help to improve surgical care and reduce the overall burden on healthcare system.
|