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

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 Overview

• Status: Completed
• Conditions: Rectal Cancer
• Intervention / Treatment: Dietary supplement: PHGG; Other: conventional care

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Putrajaya, Malaysia, 62250
    • National Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Dietary supplement: PHGG; Subjects 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.
Other: 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.	Other: conventional care; follow low fibre diet and anti-diarrhea drugs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ileostomy stoma output	consistency (bristrol stool chart; range 1-7; 1 hard while 7 watery)	up to 1 month
ileostomy stoma output	volume (ml)	up to 1 month

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Universiti Putra Malaysia
• Collaborators: National Cancer Institute, Malaysia
• Investigators: Principal Investigator: ChiouYi Ho, Department of Dietetics and Food Service, Institut Kanser Negara

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Actual): September 28, 2021
• Study Completion (Actual): November 29, 2021

Study Registration Dates

• First Submitted: November 24, 2020
• First Submitted That Met QC Criteria: December 16, 2020
• First Posted (Actual): December 21, 2020

Study Record Updates

• Last Update Posted (Actual): November 4, 2022
• Last Update Submitted That Met QC Criteria: November 1, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: NMRR-19-3119-51323

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No