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CTRI Number  CTRI/2023/05/052864 [Registered on: 18/05/2023] Trial Registered Prospectively
Last Modified On: 27/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   A prospective observational study to assess frailty status of Indian adult patients undergoing major abdominal cancer surgery using a clinical validated questionnaire and novel approach of assessing thigh muscle thickness using ultrasonography and predicting postoperative length of hospital stay  
Scientific Title of Study   Impact of preoperative frailty in predicting postoperative length of hospital stay in adult patients undergoing major abdominal cancer surgery- 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  Dr Juhi Sharma 
Designation  Academic Senior Resident 
Affiliation  AIIMS, New Delhi 
Address  Dept of Oncoanesthesia and Palliative Medicine Dr BR Ambedkar IRCH AIIMS, New Delhi Ansari nagar

South
DELHI
110029
India 
Phone  9634705218  
Fax    
Email  jsharm92.iz@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Dr Sushma Bhatnagar 
Designation  Chief and Head 
Affiliation  AIIMS, New Delhi 
Address  Dept of Oncoanesthesia and Palliative Medicine Dr BR Ambedkar IRCH AIIMS, New Delhi Ansari nagar

South
DELHI
110029
India 
Phone  9811326453  
Fax    
Email  sushmabhatnagar1@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Prof Dr Sushma Bhatnagar 
Designation  Chief and Head 
Affiliation  AIIMS, New Delhi 
Address  Dept of Oncoanesthesia and Palliative Medicine Dr BR Ambedkar IRCH AIIMS, New Delhi Ansari nagar

West
DELHI
110029
India 
Phone  9811326453  
Fax    
Email  sushmabhatnagar1@gmail.com  
 
Source of Monetary or Material Support  
Dept of Oncoanesthesia and Palliative Medicine Dr BR Ambedkar Institute Rotary Cancer Hospital AIIMS, New Delhi 
 
Primary Sponsor  
Name  Dr BRA Irch AIIMS New Delhi 
Address  Dept of Oncoanaesthesia and Palliative medicine Dr BRA Irch AIIMS, New Delhi 
Type of Sponsor  Government medical college 
 
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 
Juhi Sharma  AIIMS, New Delhi  Dept of Oncoanesthesia and Palliative Medicine Dr BR Ambedkar IRCH AIIMS, New Delhi
South
DELHI 
9634705218

jsharm92.iz@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Institute Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K929||Disease of digestive system, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1.Adults more than 18years old
2.Adult patients undergoing major abdominal cancer surgery defined as surgery having skin incision, an expected operative duration of at least 2 hours, and an expected hospital stay of at least 3 days
 
 
ExclusionCriteria 
Details  1. Refusal / unable to provide written consent
2. Patients with disease affecting the muscles
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Effect of frailty as assessed by Fried Frailty Index on Hospital LOS
•  
1. till hospital stay 
 
Secondary Outcome  
Outcome  TimePoints 
1. To find the optimal cut off values of quadriceps thickness and rectus femoris CSA using ultrasonography to classify frail and not frail
2.Postoperative surgical complications as defined by Clavien – Dindo classification
3.Correlation with APACHE II score in SICU
4.Effect of frailty as assessed by fried questionnaire on ICU length of stay
 
Preoperatively to postoperatively 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="160" 
Phase of Trial   N/A 
Date of First Enrollment (India)   05/06/2023 
Date of Study Completion (India) 10/10/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

Though age is directly correlated with frailty, it is not an inevitable component. Multiple frailty assessment tools are being created on the basis of clinical judgement which are subjective and time- consuming  Further, none of them is a gold standard for identifying frailty. Most of the frailty indexes require patient cooperation and ability to walk which might not be possible in a subset of frail patients.  Hence, an objective, quick tool is required to identify frailty in perioperative settings. Sarcopenia is a functional marker for frailty that can be quantified objectively. Computed tomography is an objective but expensive and resource-intensive tool for assessing sarcopenia by measuring psoas muscle area. Further, it exposes patients to radiations.

Bedside ultrasound is a quick, bedside tool that can determine sarcopenia in perioperative settings without any harmful effects. It can be used to identify frail population preoperatively, and hence, has a potential in risk – stratification of patients. 

Previous observational studies are done in western population undergoing heterogenous surgeries to discriminate between frail and not-frail patients using ultrasound. However, the type of surgery can have a confounding impact on the postoperative outcome. Further no studies are conducted on Indian population. Hence, we propose to conduct a prospective, single center, observational study in Indian patients undergoing major abdominal surgery to determine if ultrasound guided quadriceps thickness can be used as a sensitive tool in differentiating between frail and not- frail patients, thereby predicting adverse postoperative outcomes.

 
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