| CTRI Number |
CTRI/2025/12/100001 [Registered on: 31/12/2025] Trial Registered Prospectively |
| Last Modified On: |
11/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
prospective |
| Study Design |
Other |
|
Public Title of Study
|
How Muscle Health Affects Outcomes in Patients Undergoing Abdominal Operations |
|
Scientific Title of Study
|
To study the functional and radiological assessment of sarcopenia in patient undergoing visceral surgeries |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Upender Sharma |
| Designation |
Junior Resident |
| Affiliation |
Command Hospital Lucknow |
| Address |
Department Of Surgery
Command Hospital
Lucknow
Lucknow
UTTAR PRADESH
226002
India |
| Phone |
9857435033 |
| Fax |
|
| Email |
sharmaupender47@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
R Saranga Bharathi |
| Designation |
Professor |
| Affiliation |
Command Hospital Lucknow |
| Address |
Department Of Surgery
Command Hospital
Lucknow
Lucknow
UTTAR PRADESH
226002
India |
| Phone |
8554061554 |
| Fax |
|
| Email |
sarangabharathi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
R Saranga Bharathi |
| Designation |
Professor |
| Affiliation |
Command Hospital Lucknow |
| Address |
Department Of Surgery
Command Hospital
Lucknow
Lucknow
UTTAR PRADESH
226002
India |
| Phone |
8554061554 |
| Fax |
|
| Email |
sarangabharathi@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Upender Sharma |
| Address |
Department Of Surgery
Command Hospital
Lucknow |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Upender Sharma |
Command hospital lucknow |
Surgical division room no 4
Lucknow
UTTAR PRADESH |
9857435033
sharmaupender47@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Command Hospital Central Command Lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C269||Malignant neoplasm of ill-definedsites within the digestive system, (2) ICD-10 Condition: M625||Muscle wasting and atrophy, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are undergoing elective visceral surgeries and who are above the age of 18 years are included |
|
| ExclusionCriteria |
| Details |
Patients unable to do physical performance test and those with physical deformities and reduced mobility or bedridden patients
Patients who refused to participate in study
Patients operated upon in emergency |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the association of sarcopenia by way of iliopsoas muscle thickness and timed stair climbing with the surgical outcome in visceral surgeries |
04 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/01/2026 |
| 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="2"
Months="0"
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 that aims at studying the association of sarcopenia by way of iliopsoas muscle thickness with the help of CT and timed stair climbing with the surgical outcome in patients who are undergoing visceral surgeries |