Clinical trial NCT06816836: Measuring Ultrasound Guided Skeletal Muscle Mass of Lower Extremity as a Predictor of Post-Operative Length of Stay in Exploratory Gynae-oncology Surgeries
Official title: Measuring Ultrasound Guided Skeletal Muscle Mass of Lower Extremity as a Predictor of Post-Operative Length of Stay in Exploratory Gynae-oncology Surgeries
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gynecologic Cancer
Frailty
Sarcopenia
Keywords: Gynecologic Cancer
Post operative Stay
Frailty
Sarcopenia
Lead sponsor: Tata Medical Center
Sponsor class: OTHER
First posted: 2025-02-10
Enrollment: 320
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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)

Primary outcomes:
measure: Prolonged length of hospital stay
timeFrame: 3 Years
Secondary outcomes:
measure: Incidence of severe morbidity as classified by the Clavien Dindo Score.
timeFrame: 3 years
measure: Type of morbidity as defined by the Post Operative Morbidity Survey.
timeFrame: 3 years
measure: 30-day and 90-day readmission
timeFrame: 3 years
measure: 30-day and 90-day mortality.
timeFrame: 3 years
Other outcomes:
Locations:
city: Kolkata
country: India
facility: Tata Medical Center
state: West Bengal
Study officials:
References: