| CTRI Number |
CTRI/2023/07/055906 [Registered on: 31/07/2023] Trial Registered Prospectively |
| Last Modified On: |
28/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
outcome of frail patients during and after surgery |
|
Scientific Title of Study
|
Correlation of frailty index with perioperative outcomes in the elderly patients undergoing surgeries |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Col Dr Parikshit Singh |
| Designation |
Professor |
| Affiliation |
Command Hospital (Eastern Command) |
| Address |
Operation Theatre Complex, Department of Anaesthesiology and Critical Care, Command Hospital (Eastern Command)
Kolkata
WEST BENGAL
700027
India |
| Phone |
8412809391 |
| Fax |
|
| Email |
drparikshitsingh@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Maj Dr Deepika Jha |
| Designation |
Post Graduate Resident |
| Affiliation |
Command Hospital(Eastern Command) |
| Address |
PG Resident Room, Department of Anaesthesiology and Critical Care, Command Hospital (Eastern Command)
Kolkata
WEST BENGAL
700027
India |
| Phone |
9682325245 |
| Fax |
|
| Email |
deepikajhaonline@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Maj Dr Deepika Jha |
| Designation |
Post Graduate Resident |
| Affiliation |
Command Hospital(Eastern Command) |
| Address |
PG Resident Room, Department of Anaesthesiology and Critical Care, Command Hospital (Eastern Command)
WEST BENGAL
700027
India |
| Phone |
9682325245 |
| Fax |
|
| Email |
deepikajhaonline@gmail.com |
|
|
Source of Monetary or Material Support
|
| Command Hospital Eastern Command,Kolkata |
|
|
Primary Sponsor
|
| Name |
Command Hospital Eastern Command |
| Address |
17/1E,Alipore Rd, Alipore Police line ,Alipore, Kolkata, West Bengal,700027 |
| Type of Sponsor |
Other [INDIAN ARMY(Army Medical Corps)] |
|
|
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 |
| Maj Dr Deepika Jha |
Command Hospital Eastern Command |
operation theatre complex , department of anaesthesiology and critical care , command hospital eastern command ,kolkata
Kolkata
WEST BENGAL |
9682325245
deepikajhaonline@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE COMMAND HOSPITAL EASTERN COMMAND |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z69-Z76||Persons encountering health services in other circumstances, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
observational study |
nil |
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged more than 65 years undergoing surgeries
ASA-II and above
Length of hospital stay upto 2 weeks post surgery.
|
|
| ExclusionCriteria |
| Details |
ASA-1
Patients <65 years
Cataract surgeries/minor procedures in local anaesthesia
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To correlate frailty index in patients older than 65 yrs of age with perioperative morbidity & mortality .
|
upto 2 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate postoperative complications, & length of hospital stay post surgery. |
upto 2 weeks |
|
|
Target Sample Size
|
Total Sample Size="238"
Sample Size from India="238"
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)
|
09/08/2023 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Frailty ,an emerging public health concern worldwide paralleled with population aging ,is conceptualised in two major ways: one includes decreased reserve to physiologic stress and is characterised by decline across organ systems and the other is an accumulation of deficits ,that is, the accumulation of comorbid states that can result in overall physiologic vulnerability. This condition increases the risk of a range of adverse health outcomes, including disability, falls,fractures, lower quality of life, loneliness, cognitive decline, hospital admission, major cardiovascular events and mortality. The study aims to determine the clinical utility of frailty as a preoperative assessment .Also Correlating frailty index in patients older than 65 years of age with peri operative morbidity and mortality with postoperative complications and length of hospital stay post surgery. |