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

Not Applicable

Completed

• Conditions: Rectal Cancer
• Interventions: Other: conventional care; Dietary Supplement: PHGG

• Registration Number: NCT04678349
• Lead Sponsor: Universiti Putra Malaysia

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-24
• Study First Submitted QC: 2020-12-16
• Study First Posted: 2020-12-21
• Study Start: 2021-05-01
• Primary Completion: 2021-09-28
• Study Completion: 2021-11-29
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-01
• Last Update Posted: 2022-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CG	conventional care	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.
PHGG	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.

Primary Outcome Measures

Name	Time	Method
ileostomy stoma output	up to 1 month	volume (ml)

Secondary Outcome Measures

Name	Time	Method
Length of hospital stay	up to 1 month	days of hospital stays
Readmission within 30-days discharged	up to 1 month	readmit to ward due to complications after discharge
Dietary intake	up to 1 month	energy (kcal/day)
dietary intake	up to 1 month	protein intake (g/day)

Trial Locations

Locations (1)

National Cancer Institute; 🇲🇾 Putrajaya, Malaysia