Measuring Ultrasound Guided Skeletal Muscle Mass of Lower Extremity as a Predictor of Post-Operative Length of Stay in Exploratory Gynae-oncology Surgeries (MUSLES)

Increased incidence of Gynae-oncological cancer is observed specifically in women above 50 years of age. Sarcopenia (a progressive and generalized loss of skeletal muscle mass, quality, and strength) is considered a reliable indicator of frailty, a poor prognostic factor in these patients. Various frailty scores and measurement of psoas muscle mass are time consuming, can't be done in patients unable to walk and altered mental status. The investigators wanted to evaluate if bedside ultrasound guided skeletal muscle measurement, as a measure of sarcopenia, can be used to predict post operative length of stay.

Study Overview

• Status: Recruiting
• Conditions: Gynecologic Cancer; Frailty; Sarcopenia
• Intervention / Treatment: Procedure: Bed Side ultrasound guided muscle mass estimation of lower extremity

Detailed Description

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.

The investigators 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 patients 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 patients above the age of 50 years undergoing open gynae- oncology surgery.

The investigators 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.

• Study Type: Observational
• Enrollment (Estimated): 320

Contacts and Locations

Study Locations

• India
  • West Bengal
    • Kolkata, West Bengal, India, 700160
      • Recruiting
      • Tata Medical Center
      • Contact: Rakhi Rakhi, MD; Phone Number: 9051133005; Email: rakhi.mittal@tmckolkata.com
      • Principal Investigator: Rakhi Rakhi, MD
      • Sub-Investigator: Amartya Chaudhuri, MD
      • Sub-Investigator: Jaydip Bhaumik, MS
      • Sub-Investigator: Shikhar More, DM
      • Sub-Investigator: Subhashree Rout, MS
      • Sub-Investigator: Priya Ghosh, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients above 50 years of age, with Charlson Comorbidity Index Score of 3 or more, presenting to the gynaecological oncology OPD with Gynacological Cancer to be treated with open surgery.

Description

Inclusion Criteria:

• All consecutive consenting patients above 50 years of age, having a Charlson Comorbidity Index score of 3 or more, undergoing open surgeries for GCs.

Exclusion Criteria:

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
GC Patients, CCI Score 3+; All consecutive consenting Gynecological Cancer patients above 50 years of age undergoing open surgical intervention, with Charlson Co-morbidity Index score of 3 or more.	Procedure: Bed Side ultrasound guided muscle mass estimation of lower extremity; Bed Side ultrasound guided muscle mass estimation of psoas major, rectus femoris, vastus intermedius and tibialis anterior.; Other Names: Preoperative Charlson's comorbidity index scoring; Frailty by using Fried phenotype score; Markers of Sarcopenia from Abdominal pelvic CT scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prolonged length of hospital stay	Length of hospital stay above 3rd Quartile at 9 days	3 Years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of severe morbidity as classified by the Clavien Dindo Score.	Incidence of severe morbidity as classified by the Clavien Dindo Score.	3 years
Type of morbidity as defined by the Post Operative Morbidity Survey.	Type of morbidity as defined by the Post Operative Morbidity Survey.	3 years
30-day and 90-day readmission	Readmission within 30 day/ 90 days from the day of discharge	3 years
30-day and 90-day mortality.	Mortality within 30 day/ 90 days from the day of discharge	3 years

Collaborators and Investigators

• Sponsor: Tata Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: February 4, 2025
• First Submitted That Met QC Criteria: February 4, 2025
• First Posted (Actual): February 10, 2025

Study Record Updates

• Last Update Posted (Actual): May 29, 2025
• Last Update Submitted That Met QC Criteria: May 22, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Sarcopenia; Frailty; Gynecologic Cancer; Post operative Stay
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Pathologic Processes; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Frailty; Sarcopenia
• Other Study ID Numbers: 2024/TMC/344/IRB66

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No