FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/04/051728 [Registered on: 18/04/2023] Trial Registered Prospectively
Last Modified On: 17/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Risk of complications after surgery in older population 
Scientific Title of Study   Relationship between frailty and incidence of postoperative complications in older patients undergoing urological procedures– A prospective observational study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sarah Sharma 
Designation  Post Graduate Student 
Affiliation  Christian Medical College, Vellore 
Address  Department of Anesthesia, Christian Medical College, Vellore

Vellore
TAMIL NADU
632004
India 
Phone  8360187164  
Fax    
Email  sarahsharma94@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Georgene Singh 
Designation  Professor 
Affiliation  Christian Medical College, Vellore 
Address  Department of Anesthesia, Christian Medical College, Vellore

Vellore
TAMIL NADU
632004
India 
Phone  9443292504  
Fax    
Email  georgenesingh@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Georgene Singh 
Designation  Professor 
Affiliation  Christian Medical College, Vellore 
Address  Department of Anesthesia, Christian Medical College, Vellore

Vellore
TAMIL NADU
632004
India 
Phone  9443292504  
Fax    
Email  georgenesingh@gmail.com  
 
Source of Monetary or Material Support  
Fluid Research Grant 
 
Primary Sponsor  
Name  Fluid Research Grant 
Address  Christian Medical College, Vellore, Tamil Nadu 632004 
Type of Sponsor  Research institution and hospital 
 
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 
Sarah Sharma  Christian Medical College  Department of Urology, Ranipet Campus, Christian Medical College
Vellore
TAMIL NADU 
8360187164

sarahsharma94@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutonal Review Board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z768||Persons encountering health services in other specified circumstances,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients more than 60 years of age undergoing urological procedures requiring anaesthesia 
 
ExclusionCriteria 
Details  1. Patients refusing to participate in the study.
2. Recent MI, Pneumonia, CVA, AKI or any other severe Acute event within last 3 months.
3. Any Recent illness requiring hospitalisation within last 3 months.
4. Non-Ambulating Patients.
5. Stage III, IV carcinoma and patients with disseminated disease.
6. Post chemotherapy/radiotherapy patients.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Primary outcome of this study will be to find relationship between Frailty, as assessed by Fried’s criteria and Clinical Frailty Scale and postoperative anaesthetic and surgical complications as assessed by Clavien Dindo Classification.  Fraility will be assessed 1 day prior to surgery and patient will be followed up post operatively for post operative complications, till discharge. Quality of recovery will be assessed 24 hours after surgery. 
 
Secondary Outcome  
Outcome  TimePoints 
Quality of Recovery as assessed by Modified Aldrete Score and QoR 15 scale.  These will be applied 24 hours after surgery. 
Incidence of post anaesthesia Delirium in Frail patients, assessed by CAM scale  24 hours post-surgery 
Incidence of new onset cognitive impairment as assessed by a repeat 3-word recall and clock draw test (Mini Cog)   24 hours post-surgery  
Comparison of Clinical Frailty Scale and Fried’s Criteria.  Both applied 1 day before the 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)   01/05/2023 
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="0"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details
Modification(s)  
None 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

Frailty, though not specifically defined, is described as a state of reduced physiological reserves and increased vulnerability to developing dependency and/or mortality when exposed to stressors and a limited ability to compensate and recover from the same.

 Surgery and anaesthesia are often a major stressor, and current preoperative evaluation methods still fail to properly estimate the perioperative risk in the elderly. Frailty not only affects mortality rates but is also associated with higher rates of complications and hospitalizations, underlining the threat of lasting physical and cognitive disability following surgery. Frail patients often undergo standard care without appropriate attention or preparation, erroneously expecting the same rate of recovery and functional improvement as their non frail peers.  Frailty measurement is essential for guiding patient care, as it may help clinicians decide which interventions will more likely be beneficial and which may be harmful to specific individuals.

There are many tools to measure frailty that consider a variety of factors including physical function, cognition, comorbidities, self-reported state of health and clinical judgment. A few of them being the Physical Frailty Phenotype (PFP), Deficit Accumulation Index (DAI), the Edmonton Frail Scale (EFS), the Johns Hopkins Adjusted Clinical Groups (JHACG) frailty assessment, the modified Frailty Index 11 (mFI 11), the Fried frailty criteria and the Clinical Frailty Scale

Quality of Recovery (QoR) after anaesthesia is an important measure of the early postoperative health status of the patient. The QoR 15 score provides a valid, extensive and  efficient evaluation of postoperative quality of recovery.

This study aims to assess frailty in patients ≥60 years of age using a questionnaire incorporating both Fried criteria and Clinical Frailty Scale, either at the preoperative anaesthesia clinic or in the peripheral wards. Further, it aims to identify the relationship between frailty status and postoperative complications and quality of recovery in patients undergoing urological surgeries. This analysis does not include patients with emergency procedures or procedures without anaesthesia contribution or operation. This study will also help us determine whether Frailty assessment should be included in routine preanesthetic workup of elderly. This knowledge will help us to tailor-make the management plan for each patient, including surgical and anaesthetic technique, adequate optimisation prior to surgery and in certain indicated cases even reconsidering non-surgical management so as to provide a better quality of recovery.

 
Close