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临床试验/NCT03667755
NCT03667755已完成不适用

Fast Track Recovery Feeding With a Whey Protein Infused Carbohydrate Loading Drink and Early Oral Feeding Among Surgical Gynecologic Oncology Patients: A Pragmatic Opened Labelled Trial

Universiti Putra Malaysia2 个研究点 分布在 1 个国家目标入组 118 人开始时间: 2017年10月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
118
试验地点
2
主要终点
length of clear fluid toleration

研究概览

简要总结

opened labelled randomised trial. Participants will be randomly divided into control & intervention group during admission to hospital using random numbers. Participants were randomized into two groups: the carbohydrate-protein (CHO-P) group and control (CO) group. Participants were given a specific drink to their group on the evening prior to surgery and three hours before operation. The CHO-P group received 474ml (evening drink) or 237ml (3hours prior to operation drink) of a solution contain 14% whey protein, 86% carbohydrates and 0% lipids and the CO group nil-by-mouth at 12 midnight day of operation. All participants fasted for solids for 6 hours from the operation.

详细描述

Candidates will attend Multidisciplinary Clinic (MDC) as appointment date for examination then they will get surgery appointment (admit to ward) 7-14 days after MDC date. Eligible patients will be identified from name list available in the electronic medical record. Selection of patient will be done by assigned research team member then she will approach and inform with study procedures to all potential candidates (selected based on inclusion and exclusion criteria) while they attend MDC during study period. Participants will be randomized into two groups: the carbohydrate-protein (CHO-P) group and conventional (CO) group during admission to hospital via random numbers which are issued by computer program. For the concepts of the CONSORT flow diagram are followed [50]. The Patient Information Consent Form will be given to identify eligible subjects who agreed to be recruited in the study. Subjects are allowed to bring back consent form if she keen to seek advice from family member.

Carbohydrate-protein group: Participants will attend dietitian clinic to have anthropometry & dietary assessment on the same day of admission (before admission). Subjects are given a specific drink to their group on the evening prior to surgery and three hours before operation. The CHO-P group received 474ml (evening drink) or 237ml (3 hours prior to operation drink) of a lactose-free clear tea-colour fruit flavoured fluid contains 14% whey protein, 86% carbohydrates and 0% lipids. Participants fast for solids for 6 hours from the operation. Participants will be given clear fluid (2 packs Resource peach) within 24 hours post-surgery (without present of bowel sound) and reviewed by dietitian. Staff nurse in-charged will monitor anesthetic risk of drinking whey protein and ensure subject to finish specific drinks prior surgery. When they tolerated at least 500ml of clear fluids, they were given a regular solid diet.

Conventional group: Participants will attend dietitian clinic to have anthropometry & dietary assessment on the same day of admission (before admission). Participants followed conventional operation procedure whereby fasting start 12am until operation. On the first day of post-operation day, participants will be reviewed by gynaecologist and dietitian. They are allowed for clear fluid once there is bowel sound. After tolerated clear fluid, they will proceed for nourishing fluid, then soft diet and they were given a regular solid diet.

On the day of operation and on the first day of post-operative day, blood samples are collected for hemoglobin, renal profile, albumin and C-reactive protein. Biochemical data will be record from electronic medical record. Upon discharge, all participants will be sent to dietitian clinic to assess anthropometry and dietary data.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • who diagnosed with Gynecologic Cancer stage 1 to stage 4
  • candidates for elective operation treatments
  • Malaysian aged more than 18 years old

排除标准

  • Not a candidate for elective operation treatments
  • Aged <18 years old
  • Diagnosed with Diabetes Mellitus/Chronic Kidney Disease/Heart disease/Chronic liver disease
  • Allergy to milk/soy/whey protein
  • participate other intervention study

结局指标

主要结局

length of clear fluid toleration

时间窗: throughout hospitalization (up to 1 week)

period of clear fluid toleration post-operation

length of post-operative hospital stay

时间窗: throughout hospitalization (up to 2 weeks)

period of hospitalization after operation to discharged

length of solid food toleration

时间窗: throughout hospitalization (up to 2 weeks)

period of solid food toleration post-operation

次要结局

  • height(throughout hospitalization (up to 2 weeks))
  • inflammatory effect(on day of operation (before operation and 12 hours after operation))
  • dietary intake trend during hospitalization(daily energy and protein intake throughout hospitalization (up to 2 weeks))
  • post-operative complications(throughout hospitalization (up to 2 weeks))
  • Body Mass Index(throughout hospitalization (up to 2 weeks))
  • re-admission(1 month post-operation)
  • muscle mass(throughout hospitalization (up to 2 weeks))
  • weight(throughout hospitalization (up to 2 weeks))
  • handgrip strength(throughout hospitalization (up to 2 weeks))

研究者

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

HO CHIOU YI

Dietitian

Universiti Putra Malaysia

研究点 (2)

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