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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age50-99
SponsorTata Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Bed Side ultrasound guided muscle mass estimation of lower extremity

    Procedure/Surgery

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

Treatment groups

320 Participants
are divided into 1 treatment group
Group A: GC Patients, CCI Score 3+1 intervention

Trial outcomes

Primary outcomes

1

Prolonged length of hospital stay

Length of hospital stay above 3rd Quartile at 9 days

Time frame
3 Years

Secondary outcomes

1

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
2

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
3

30-day and 90-day readmission

Readmission within 30 day/ 90 days from the day of discharge

Time frame
3 years
4

30-day and 90-day mortality.

Mortality within 30 day/ 90 days from the day of discharge

Time frame
3 years

Other outcomes

Sponsors and contacts

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