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临床试验/CTRI/2025/02/080415
CTRI/2025/02/080415招募中不适用

Measuring Ultrasound Guided Skeletal Muscle Mass of Lower Extremity as a Predictor of Post-operative Length of Stay in Exploratory Gynae-Oncology surgeries

Dr Rakhi Khemka1 个研究点 分布在 1 个国家目标入组 320 人开始时间: 2025年3月1日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
320
试验地点
1
主要终点
Prolonged length of hospital stay, defined as length of stay more than 3rd quartile in the cohort.

研究概览

简要总结

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.

We 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 moderate to high risk patients (Charlson Comorbidity Index score of 3 or more) of 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, in moderate-to-high risk patients above the age of 50 years undergoing open gynae-oncology surgery.

We 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.

The outcome measured will be:

Primary outcome: Prolonged length of hospital stay.

Secondary outcomes:

• Incidence of severe morbidity as classified by the Clavien Dindo Score.

• Type of morbidity as defined by the Post Operative Morbidity Survey

• 30-day and 90-day readmission.

• 30-day and 90-day mortality.

All the data collected will be analyzed by appropriate statistical methods and the study will be concluded

研究设计

研究类型
Observational

入排标准

年龄范围
50.00 Year(s) 至 99.00 Year(s)(—)
性别
Female

入选标准

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

排除标准

  • Refusal of consent.
  • Patients with psychiatric illnesses who are unable to follow instructions.
  • Patients below the age of 50 years.
  • Patients with known neuromuscular disorders.
  • Patients in whom contrast-enhanced CT scan of the abdomen and pelvis is not done.
  • Previous major surgery of limbs (Amputation, Hip surgeries/ Long bone surgeries).

结局指标

主要结局

Prolonged length of hospital stay, defined as length of stay more than 3rd quartile in the cohort.

时间窗: 2 years 6 months

次要结局

  • Incidence of severe morbidity as classified by the Clavien Dindo Score.(2 years 6 months)
  • Type of morbidity as defined by the Post Operative Morbidity Survey(2 years 6 months)
  • 30-day and 90-day readmission(2 years 6 months)
  • 30-day and 90-day mortality(2 years 6 months)

研究者

发起方
Dr Rakhi Khemka
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Rakhi Khemka

Tata Medical Center

研究点 (1)

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