| CTRI Number |
CTRI/2024/11/076408 [Registered on: 08/11/2024] Trial Registered Prospectively |
| Last Modified On: |
07/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Muscle ultrasound for assessment of loss of muscle mass and strength and study its association with Frailty and short-term postoperative outcomes in patients undergoing oncosurgery |
|
Scientific Title of Study
|
Role of Muscle Ultrasonography to assess Sarcopenia and its association with Frailty and short-term postoperative outcomes in oncosurgical patients - A Prospective Observational Study |
| 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 Shivanya Singh |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences, Bhopal |
| Address |
Department of Anaesthesiology, 3rd Floor, AIIMS BHOPAL campus, AIIMS BHOPAL, Saket Nagar, Bhopal, Madhya Pradesh, India
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
9810291836 |
| Fax |
|
| Email |
shivanyasingh111@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vaishali Waindeskar |
| Designation |
Professor and Head of Department |
| Affiliation |
All India Institute of Medical Sciences, Bhopal |
| Address |
Department of Anaesthesiology, 3rd Floor, AIIMS BHOPAL campus, AIIMS BHOPAL, Saket Nagar, Bhopal, Madhya Pradesh, India
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
9575604490 |
| Fax |
|
| Email |
vaishali.anesth@aiimsbhopal.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vaishali Waindeskar |
| Designation |
Professor and Head of Department |
| Affiliation |
All India Institute of Medical Sciences, Bhopal |
| Address |
Department of Anaesthesiology, 3rd Floor, AIIMS BHOPAL campus, AIIMS BHOPAL, Saket Nagar, Bhopal, Madhya Pradesh, India
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
9575604490 |
| Fax |
|
| Email |
vaishali.anesth@aiimsbhopal.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Bhopal |
| Address |
All India Institute of Medical Sciences, Bhopal, Saket Nagar, Bhopal 462020, Madhya Pradesh, India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Shivanya Singh |
All India Institute Of Medical Sciences, Bhopal |
Department of Anaesthesiology, Modular OT Complex 3rd Floor, Hospital Building, All India Institute of Medical Sciences, Bhopal 462020, Madhya Pradesh, India
Bhopal
MADHYA PRADESH |
9810291836
shivanyasingh111@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee -Student Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged over 50 years of either sex undergoing elective oncological surgery under general anaesthesia. |
|
| ExclusionCriteria |
| Details |
1.Neuromuscular diseases
2.Paresis
3.Paralysis or limb amputation
4.Dementia
5.Emergency surgery
6.Spinal cord injury
7.Obesity(male BMI≥35kg/m2,female BMI≥34.35kg/m2)
8.Acute heart failure, acute myocardial infarction, acute stroke |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Correlation coefficient of Muscle USG parameters with muscle strength (as assessed by hand-grip strength measured by dynamometer).
2.Correlation coefficient of Muscle USG parameters with physical function status (as assessed by gait speed on four-meter walk test). |
One day before surgery.
Muscle USG, hand grip strength by dynamometer and gait speed (four meter walk test) will be performed on all patients one day before surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Correlation coefficient of USG parameters with frailty as assessed by Frail Q- Score
2.Association of measured sarcopenia with short-term postoperative outcomes (day of extubation, length of hospital & ICU stay, morbidity (Clavien-dindo scale), mortality until discharge). |
Frailty by FRAIL-Q (questionnaire) will be assessed one day before surgery.
Postoperative outcomes will be evaluated on day of extubation, discharge from ICU & discharge from hospital. |
|
|
Target Sample Size
|
Total Sample Size="86"
Sample Size from India="86"
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)
|
20/11/2024 |
| 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="6"
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
|
This is a Prospective Observational study to evaluate the role of Muscle ultrasonography in assessing Sarcopenia and its association with Frailty and short-term postoperative outcomes in oncosurgical patients. Muscle ultrasound will be used to measure both quantitative(muscle thickness) and qualitative (echogenic intensity) parameters, muscle strength will be measured with a hand grip dynamometer and gait speed( functional status) by four-meter walk test. All parameters will be measured one day before surgery. As Primary outcome we aim to measure the correlation of USG parameters with muscle strength and gait speed. As secondary outcome we also aim to study the association of the USG parameters with Frailty (assessed by FRAIL-Q, one day before surgery) and short-term postoperative outcome ( Clavien Dindo classification) until discharge of patient from hospital. |