An observational study in Gynecologic Cancer, Frailty and Sarcopenia, sponsored by Tata Medical Center. Recruiting at 1 site in India. Open to female participants aged 50 Years to 99 Years. Per ClinicalTrials.gov, last updated 2025-05-29.
Sponsored by Tata Medical Center · Observational
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.
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.
1,208 studies on the registry are indexed under Sarcopenia; 402 are open to participants now.
This study's planned enrollment of 320 is above the median of 120 across 419 observational studies indexed under Sarcopenia.
Browse Sarcopenia studies →Tata Medical Center is the lead sponsor of 10 studies on the registry; 3 are open to participants now.
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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.
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)
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.
Also known as: Preoperative Charlson's comorbidity index scoring, Frailty by using Fried phenotype score, Markers of Sarcopenia from Abdominal pelvic CT scan
Prolonged length of hospital stay
Length of hospital stay above 3rd Quartile at 9 days
Time frame: 3 Years
Incidence of severe morbidity as classified by the Clavien Dindo Score.
Incidence of severe morbidity as classified by the Clavien Dindo Score.
Time frame: 3 years
Type of morbidity as defined by the Post Operative Morbidity Survey.
Type of morbidity as defined by the Post Operative Morbidity Survey.
Time frame: 3 years
30-day and 90-day readmission
Readmission within 30 day/ 90 days from the day of discharge
Time frame: 3 years
30-day and 90-day mortality.
Mortality within 30 day/ 90 days from the day of discharge
Time frame: 3 years
Plan to share: No
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