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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.
Age
50 - 99 years
Sex
FEMALE
Healthy Volunteers
No
Tata Medical Center
Kolkata, West Bengal, India
Start Date
April 1, 2025
Primary Completion Date
September 30, 2027
Completion Date
September 30, 2027
Last Updated
May 29, 2025
320
ESTIMATED participants
Bed Side ultrasound guided muscle mass estimation of lower extremity
PROCEDURE
Lead Sponsor
Tata Medical Center
NCT05884138
NCT07469761
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT07447050