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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: K929||Disease of digestive system, unspecified, |
|
Intervention / Comparator Agent
|
|
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. |