| CTRI Number |
CTRI/2025/02/080415 [Registered on: 12/02/2025] Trial Registered Prospectively |
| Last Modified On: |
05/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Measuring thickness of the leg muscle to know beforehand the number of days of hospital stay after surgery in female patients having cancer surgery of their reproductive system. |
|
Scientific Title of Study
|
Measuring Ultrasound Guided Skeletal Muscle Mass of Lower Extremity as a Predictor of Post-operative Length of Stay in Exploratory Gynae-Oncology surgeries |
| Trial Acronym |
MUSLES |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rakhi Khemka |
| Designation |
Consultant |
| Affiliation |
Tata Medical Center |
| Address |
Tata Medical Center, 14 MAR(EW), New Town, Rajarhat, Kolkata, India
North Twentyfour Parganas
WEST BENGAL
700160
India |
| Phone |
9051133005 |
| Fax |
|
| Email |
rakhi.mittal@tmckolkata.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rakhi Khemka |
| Designation |
Consultant |
| Affiliation |
Tata Medical Center |
| Address |
Tata Medical Center, 14 MAR(EW), New Town, Rajarhat, Kolkata, India
WEST BENGAL
700160
India |
| Phone |
9051133005 |
| Fax |
|
| Email |
rakhi.mittal@tmckolkata.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rakhi Khemka |
| Designation |
Consultant |
| Affiliation |
Tata Medical Center |
| Address |
Tata Medical Center, 14 MAR(EW), New Town, Rajarhat, Kolkata, India
WEST BENGAL
700160
India |
| Phone |
9051133005 |
| Fax |
|
| Email |
rakhi.mittal@tmckolkata.com |
|
|
Source of Monetary or Material Support
|
| Tata Medical Center, 14 MAR(EW), New Town, Rajarhat, Kolkata- 700160, India |
|
|
Primary Sponsor
|
| Name |
Dr Rakhi Khemka |
| Address |
Tata Medical Center, 14 MAR(EW), New Town, Rajarhat, Kolkata-700160, India |
| 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 |
| Dr Rakhi Khemka |
Tata Medical Center |
14 MAR(EW), New Town,Rajarhat, Kolkata-700160, India
North Twentyfour Parganas
WEST BENGAL |
9051133005
rakhi.mittal@tmckolkata.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| TATA MEDICAL CENTER INSTITUTIONAL REVIEW BOARD |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Female |
| Details |
All consecutive consenting patients above 50 years of age, having a Charlson Comorbidity Index score of 3 or more, undergoing open surgeries for gynaecological cancers. |
|
| ExclusionCriteria |
| Details |
A. Refusal of consent.
B. Patients with psychiatric illnesses who are unable to follow instructions.
C. Patients below the age of 50 years.
D. Patients with known neuromuscular disorders.
E. Patients in whom contrast-enhanced CT scan of the abdomen and pelvis is not done.
F. Previous major surgery of limbs (Amputation, Hip surgeries/ Long bone surgeries)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prolonged length of hospital stay, defined as length of stay more than 3rd quartile in the cohort. |
2 years 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of severe morbidity as classified by the Clavien Dindo Score. |
2 years 6 months |
| Type of morbidity as defined by the Post Operative Morbidity Survey |
2 years 6 months |
| 30-day and 90-day readmission |
2 years 6 months |
| 30-day and 90-day mortality |
2 years 6 months |
|
|
Target Sample Size
|
Total Sample Size="320"
Sample Size from India="320"
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)
|
01/03/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Gynae-oncological patients comprise a significant proportion of all new cancers and death related to
cancer. Abrupt increase in the incidence of these cancer is observed specifically between women of
50-60 years of age. Therefore, it is important to evaluate the factors which influence postoperative
outcomes in such patients. Sarcopenia, defined as a progressive and generalized loss of skeletal muscle
mass, quality, and strength is considered a reliable indicator of frailty, a poor prognostic factor in
cancer. Usually, various frailty scores and measurement of psoas muscle mass with the abdominal pelvic CT
scan are used as markers of sarcopenia. But these scores are time consuming, can’t be done in patients
unable to walk and altered mental status. Routine use of CT scan exposes the patient to radiation and
may not be necessary. We wanted to evaluate if bedside ultrasound guided skeletal muscle measurement, as a measure of
sarcopenia, can be used to predict adverse post operative outcomes in open gynae-oncology surgery in
moderate to high risk patients (Charlson Comorbidity Index score of 3 or more) of more than 50 years
of age. This will be a prospective observational cohort study. Total 320 patients will be recruited considering
1:1 ratio of sarcopenia vs non sarcopenia, in moderate-to-high risk patients above the age of 50 years
undergoing open gynae-oncology surgery. We will be collecting all relevant data other than skeletal muscle mass measurement (psoas major,
rectus femoris, vastus intermedius and tibialis anterior) that can contribute to adverse post operative
outcomes. In the preoperative period Charlson’s comorbidity index, Serum albumin, creatinine and
blood haemoglobin value, preoperative Functional status by 6-minute walk test, existing frailty by
using Fried phenotype score and if patient has received neoadjuvant chemotherapy will be noted.
Intraoperatively duration of surgery, Surgical complexity score, blood loss will be collected. In the
post-operative period, length of hospital stay, Clavien Dindo score, post-operative morbidity score, 30
and 90 days readmission and 30- and 90-day mortality after discharge will be noted. The outcome measured will be: Primary outcome: Prolonged length of hospital stay. Secondary outcomes: • Incidence of severe morbidity as classified by the Clavien Dindo Score. • Type of morbidity as defined by the Post Operative Morbidity Survey • 30-day and 90-day readmission. • 30-day and 90-day mortality. All the data collected will be analyzed by appropriate statistical methods and the study will be
concluded |