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

NCT06816836 | Recruiting DMC

• 1 other identifier: 2024/TMC/344/IRB66
• Study Type: observational
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gynecologic Cancer; Frailty; Sarcopenia

Keywords

Gynecologic Cancer; Post operative Stay; Frailty; Sarcopenia

Outcome Measures

Primary Outcomes (1)

• Prolonged length of hospital stay

  Length of hospital stay above 3rd Quartile at 9 days

  3 Years

Secondary Outcomes (4)

• Incidence of severe morbidity as classified by the Clavien Dindo Score.

  3 years

• Type of morbidity as defined by the Post Operative Morbidity Survey.

  3 years

• 30-day and 90-day readmission

  3 years

• 30-day and 90-day mortality.

  3 years

Study Arms (1)

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

Interventions

Bed Side ultrasound guided muscle mass estimation of lower extremity PROCEDURE

Bed Side ultrasound guided muscle mass estimation of psoas major, rectus femoris, vastus intermedius and tibialis anterior.

Also known as: Preoperative Charlson's comorbidity index scoring, Frailty by using Fried phenotype score, Markers of Sarcopenia from Abdominal pelvic CT scan

GC Patients, CCI Score 3+

Eligibility Criteria

• Age: 50 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Tata Medical Center: lead

Study Sites (1)

Tata Medical Center

Kolkata, West Bengal, 700160, India

RECRUITING

MeSH Terms

Conditions

Frailty; Sarcopenia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: February 10, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)