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临床试验/NCT04306562
NCT04306562终止不适用

Effect of Oral Protein Supplementation on Postoperative Complications in Elderly Sarcopenic Cancerous Patients: A Randomized Controlled Trial

Siriraj Hospital2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2019年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
5
试验地点
2
主要终点
Postoperative complications

研究概览

简要总结

Sarcopenia is a condition of reduced skeletal muscle associated with aging. It leads to poor outcome and increased risk of postoperative complications. Achieving protein and energy requirements is crucial point in sarcopenia treatment. In preoperative patients, daily consumption of protein should be at least 1.2-2.0 g of protein/kg/day or 25-35 g of protein in a meal to provide muscular protein synthesis.

The objective of this study is to show that preoperative enteral protein supplementation in elderly cancerous patients, who are diagnosed with sarcopenia, can decrease morbidity such as postoperative complications; mortality and improve postoperative clinical outcomes after elective surgery.

详细描述

Sarcopenia is a condition of reduced skeletal muscle mass associated with aging process leading to decrease muscle strength and function. International Working Group on Sarcopenia defines Sarcopenia as an age-associated loss of skeletal muscle mass and function, and the European Working Group on Sarcopenia in Older People (EWGSOP) defines sarcopenia as a syndrome characterized by progressive and generalized loss of skeletal muscle mass and strength with a risk of adverse outcomes such as physical disability, poor quality of life, and death. The prevalence of sarcopenia is higher in population older than 65 years and leading to poor outcomes such as mobility disorders, disability, poor quality of life and death. Sarcopenia is also associated with an increased risk of postoperative complications such as overgrowth of bacteria in the gastrointestinal tract, postoperative infections, sepsis, delayed wound healing prolonged inpatient rehabilitation, mortality and consequently a longer length of hospital stay, even without nutritional risk.

Sarcopenia contains multifactorial etiology, such as age-related, inadequate energy and/or protein intake, sedentary activity such as bed rest, and coexisting disease such as organ failure, inflammatory disease or endocrine disease. One important goal of developing treatment strategies in sarcopenic patients is to achieve protein and energy requirements. In preoperative patients, daily consumption of protein should be at least 1.2-2.0 g of protein/kg/day or 25-35 g of protein in a meal to provide muscular protein synthesis. Perioperative oral protein supplements have been demonstrated to increase serum albumin and total protein, improve postoperative functional walking capacity and decrease postoperative infection in elderly or critically ill patients. However, there have been no studies on the benefit of preoperative protein supplement in cancerous patients.

The objective of this study is to show that preoperative enteral protein supplementation in elderly cancerous patients, who are diagnosed with sarcopenia, can decrease morbidity such as postoperative complications; mortality and improve postoperative clinical outcomes after elective surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

The allocation sequence will be concealed from the researcher enrolling and assessing participants in sequentially numbered, opaque, sealed and stapled envelopes. Corresponding envelopes will be opened only after the enrolled participants completed all baseline assessments and it was time to allocate the intervention. Whereas patients and physicians allocated to the intervention group are aware of the allocated arm, outcome assessors and data analysts will be kept blinded to the allocation.

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age of equal or more than 65 years.
  • Diagnosed cancer of gastrointestinal tract, hepatopancreaticobiliary tract, urology, head and neck, ear-nose-throat or gynecological cancer.
  • Scheduled for elective surgery with the duration more than 2 hours will be enrolled in this study.

排除标准

  • Unable to walk, stand up, perform hand grip test, communicate and follow commands.
  • Having factors affect bioimpedance (BIA) analysis such as pacemaker, alcohol drinking or heavy exercise within 12 hours prior to analysis or take medication, herb or hormone that affect muscle mass and strength such as estrogen, testosterone, thyroxine, steroid.
  • Patients diagnosed with no sarcopenia or probable sarcopenia or have a contraindication for enteral nutrition will be excluded from this study.

结局指标

主要结局

Postoperative complications

时间窗: 30 days after operation

postoperative complications within 30 days after operation which will be recorded and classify into surgical or non-surgical complications. All complication will be graded using Dindo-Clavien classification into 5 grades; Grade I is any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions; Grade II is complication which requiring pharmacological treatment with drugs (other than such allowed for grade I), blood transfusions or total parenteral nutrition are also included; Grade III requires surgical, endoscopic or radiological intervention; Grade IV is life-threatening complication (including CNS complications) requiring ICU management; Grade V means death of a patient.

次要结局

  • duration of hospital admission(through patients discharge, an average of 1 week)
  • mortality rate(90 days after operation)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mingkwan Wongyingsinn, MD

Associated Professor

Siriraj Hospital

研究点 (2)

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