The Role of Partial Hydrolyzed Guar Gum in High Stoma Output Management Among Cancer Patients With Ileostomy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Universiti Putra Malaysia
- Enrollment
- 29
- Locations
- 1
- Primary Endpoint
- ileostomy stoma output
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Cancer patients with ileostomy
- •At least 18 years of age
- •Malaysian
Exclusion Criteria
- •Not cancer patients with ileostomy
- •Patients who participate in other study at the same time
- •Vulnerable subjects
- •Palliative patients
- •Patient has fistula
Arms & Interventions
PHGG
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.
Intervention: PHGG (Dietary Supplement)
CG
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.
Intervention: conventional care (Other)
Outcomes
Primary Outcomes
ileostomy stoma output
Time Frame: up to 1 month
consistency (bristrol stool chart; range 1-7; 1 hard while 7 watery)
Secondary Outcomes
- 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)
Investigators
HO CHIOU YI
Principal Investigator
National Cancer Institute, Malaysia