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

U

University of Putra Malaysia (UPM)

Status

Completed

Conditions

Rectal Cancer

Treatments

Dietary Supplement: PHGG
Other: conventional care

Study type

Interventional

Funder types

Other

Identifiers

NCT04678349
NMRR-19-3119-51323

Details and patient eligibility

About

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.

Enrollment

29 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

29 participants in 2 patient groups

PHGG
Experimental group
Description:
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.
Treatment:
Dietary Supplement: PHGG
CG
Other group
Description:
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.
Treatment:
Other: conventional care

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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