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临床试验/NCT04678349
NCT04678349已完成不适用

The Role of Partial Hydrolyzed Guar Gum in High Stoma Output Management Among Cancer Patients With Ileostomy

Universiti Putra Malaysia1 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2021年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
29
试验地点
1
主要终点
ileostomy stoma output

研究概览

简要总结

this is a cross sectional intervention study to investigate the role of partial hydrolyzed guar gum in high stoma output management among cancer patients with ileostomy. This study hypotheses there is improvement in stoma output in PHGG if compare with control. There are two groups of subjects in this study. Conventional group (CG) will include retrospective historical data (those subjects with post-operative ileostomy) from Jan 2016 to June 2019. Intervention group (PHGG) will be subjects with ileostomy which involves prospective intervention by giving partial hydrolyzed guar gum upon start orally. Data on stoma output (volume & consistency), length of hospital stay, readmission within 30-days discharged and dietary intake will be recorded in data collection form.

研究设计

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

入排标准

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

入选标准

  • •Cancer patients with ileostomy
  • •At least 18 years of age
  • •Malaysian

排除标准

  • •Not cancer patients with ileostomy
  • •Patients who participate in other study at the same time
  • •Vulnerable subjects
  • •Palliative patients
  • •Patient has fistula

研究组 & 干预措施

PHGG

Experimental

Patient who met inclusion criteria and consented during intervention period will be assigned as PHGG group. Surgical medical officer will obtain consent from eligible subject. After consented, subjects will be assessed weight and PG-SGA during admission. They will be given 4 scoops (40g) PHGG, which provide 160kcal, 0.24g protein, 30.4g soluble fibre, 40g carbohydrate and 0g sugar once allowed orally. Staff nurse in charged will monitor compliance of subject on the PHGG. Daily stoma output & consistency will be recorded and daily energy protein intake will be assessed by dietitian in charged. Renal profile will be taken daily as routine procedure for patients with ileostomy.

干预措施: PHGG (Dietary Supplement)

CG

Other

Historical records of patients with ileostomy under conventional care from January 2016 to June 2019 (before started on PHGG) will be assessed and traced retrospectively from the medical system. Data will be recorded in data collection sheet.

干预措施: conventional care (Other)

结局指标

主要结局

ileostomy stoma output

时间窗: up to 1 month

consistency (bristrol stool chart; range 1-7; 1 hard while 7 watery)

次要结局

  • Length of hospital stay(up to 1 month)
  • Readmission within 30-days discharged(up to 1 month)
  • Dietary intake(up to 1 month)
  • dietary intake(up to 1 month)

研究者

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

HO CHIOU YI

Principal Investigator

National Cancer Institute, Malaysia

研究点 (1)

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