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CTRI Number  CTRI/2026/02/103591 [Registered on: 10/02/2026] Trial Registered Prospectively
Last Modified On: 10/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   To assess frailty as predictor of perioperative outcome in Elderly patients undergoing major orthopaedic surgeries in term of hospital length of stay. 
Scientific Title of Study   Preoperative assessment of frailty as predictor of perioperative outcome in form of hospital length of stay in elderly patients undergoing major orthopaedic 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  Dr Sujeet Rai 
Designation  Professor 
Affiliation  DrRMLIMS LUCKNOW  
Address  Department of anesthesiology DrRMLIMS LUCKNOW room no.9 administrative block LUCKNOW UTTAR PRADESH INDIA 226010

Lucknow
UTTAR PRADESH
226010
India 
Phone  9161758940  
Fax    
Email  drsujeetrai@Gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sujeet Rai 
Designation  Professor 
Affiliation  DrRMLIMS LUCKNOW  
Address  Department of anesthesiology DrRMLIMS LUCKNOW room no.9 administrative block LUCKNOW UTTAR PRADESH INDIA 226010

Lucknow
UTTAR PRADESH
226010
India 
Phone  9161758940  
Fax    
Email  drsujeetrai@Gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Karn Singh Parihar 
Designation  Junior resident 
Affiliation  DrRMLIMS LUCKNOW 
Address  Department of anesthesiology DrRMLIMS LUCKNOW room no.9 administrative block LUCKNOW UTTAR PRADESH INDIA

Lucknow
UTTAR PRADESH
226010
India 
Phone  7755061336  
Fax    
Email  karnsinghparihar44444@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr. Sujeet Rai 
Address  Department of anesthesiology DrRMLIMS LUCKNOW room no.9 administrative block LUCKNOW UTTAR PRADESH INDIA 226010 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sujeet Rai  Dr Ram Manohar Lohia institute of medical sciences  Department of Anaesthesiology Dr RMLIMS LUCKNOW room no.9 Adminstrative Block Lucknow
Lucknow
UTTAR PRADESH 
9161758940

drsujeetrai@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Dr.RMLIMS   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 7||Osteopathic,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL as it is an observational study. 
 
Inclusion Criteria  
Age From  65.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients give consent for the study
Age more than equal to 65 years
Undergoing any major elective surgical procedure  
 
ExclusionCriteria 
Details  Refused to give consent for the study

Patients with severe cognitive impairment

Patients who are critically ill and unable to participate
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Postoperative outcome in form of increased hospital length of stay
Postoperative complications (e.g., infection, wound dehiscence, reoperation, ICU
transfer)
Discharge disposition (home, rehabilitation, or extended care)
In-hospital mortality.  
Till hospital stay 
 
Secondary Outcome  
Outcome  TimePoints 
Correlation between VES-13 scores & ASA grade,
Need for postoperative ICU admission,
Functional decline at discharge.  
Till hospital stay  
 
Target Sample Size   Total Sample Size="196"
Sample Size from India="196" 
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)   24/02/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  24/02/2026 
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)   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   Research hypothesis

The implementation of the Vulnerable Elders Survey 13 (VES 13) frailty tool in the 
preoperative assessment of geriatric surgical patients effectively identifies individuals at 
increased risk of adverse postoperative outcomes. It is hypothesized that patients with a 
VES-13 score more than equal to 3 will have a significantly higher incidence of postoperative 
complications, prolonged hospital stay, and non-home discharge compared to those with 
lower scores, enabling early risk stratification and targeted interventions. Aim: Assessment of the effect of frailty on perioperative outcomes in elderly patients 
undergoing major orthopaedic 

Primary objective

To assess the effect of Frailty on perioperative outcome, in the form of hospital length of 
stay on elderly patients undergoing major orthopaedic surgical procedures at Dr. 
RMLIMS, Lucknow 


Secondary objective 

To assess the effect of frailty on intra-op and post-op complications like post-op 
requirement of mechanical ventilation, requirement of vasopressors 
To assess the association with ASA grading 
To assess the association of frailty with 30 day mortality 

Primary outcome measures included 

Postoperative outcome in form of increased hospital length of stay 
Postoperative complications (e.g., infection, wound dehiscence, reoperation, ICU 
transfer) 
Discharge disposition (home, rehabilitation, or extended care) 
In-hospital mortality. 

Secondary outcomes included

Correlation between VES-13 scores and ASA grade, 
Need for postoperative ICU admission, 
Functional decline at discharge. 

Significance of the study

By doing the study, we can assess beforehand which patients are going to stay longer in 
the hospital, or have more days on mechanical ventilation, and have more chances of 
complications or mortality, so we are able to prognosticate the patient pre-operatively. 
 
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