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

NCT ID: NCT06816836

Last Updated: 2025-05-29

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 320 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2027-09-30

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.

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.

Conditions

Gynecologic Cancer; Frailty; Sarcopenia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Bed Side ultrasound guided muscle mass estimation of lower extremity

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

Preoperative Charlson's comorbidity index scoring; Frailty by using Fried phenotype score; Markers of Sarcopenia from Abdominal pelvic CT scan

Eligibility Criteria

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)

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Tata Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Tata Medical Center

Kolkata, West Bengal, India

Site Status: RECRUITING

Countries

India

Facility Contacts

Rakhi Rakhi, MD

Role: primary

rakhi.mittal@tmckolkata.com

9051133005

Other Identifiers

2024/TMC/344/IRB66

Identifier Type: -

Identifier Source: org_study_id