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

Primary Purpose

Rectal Cancer

Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
PHGG
conventional care
Sponsored by
Universiti Putra Malaysia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Rectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • National Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

PHGG

CG

Arm 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.

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.

Outcomes

Primary Outcome Measures

ileostomy stoma output
consistency (bristrol stool chart; range 1-7; 1 hard while 7 watery)
ileostomy stoma output
volume (ml)

Secondary Outcome Measures

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

Full Information

First Posted
November 24, 2020
Last Updated
November 1, 2022
Sponsor
Universiti Putra Malaysia
Collaborators
National Cancer Institute, Malaysia
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1. Study Identification

Unique Protocol Identification Number
NCT04678349
Brief Title
The Role of Partial Hydrolyzed Guar Gum in High Stoma Output Management Among Cancer Patients With Ileostomy
Official Title
The Role of Partial Hydrolyzed Guar Gum in High Stoma Output Management Among Cancer Patients With Ileostomy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
September 28, 2021 (Actual)
Study Completion Date
November 29, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiti Putra Malaysia
Collaborators
National Cancer Institute, Malaysia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PHGG
Arm Type
Experimental
Arm 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.
Arm Title
CG
Arm Type
Other
Arm 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
PHGG
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
conventional care
Intervention Description
follow low fibre diet and anti-diarrhea drugs
Primary Outcome Measure Information:
Title
ileostomy stoma output
Description
consistency (bristrol stool chart; range 1-7; 1 hard while 7 watery)
Time Frame
up to 1 month
Title
ileostomy stoma output
Description
volume (ml)
Time Frame
up to 1 month
Secondary Outcome Measure Information:
Title
Length of hospital stay
Description
days of hospital stays
Time Frame
up to 1 month
Title
Readmission within 30-days discharged
Description
readmit to ward due to complications after discharge
Time Frame
up to 1 month
Title
Dietary intake
Description
energy (kcal/day)
Time Frame
up to 1 month
Title
dietary intake
Description
protein intake (g/day)
Time Frame
up to 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ChiouYi Ho
Organizational Affiliation
Department of Dietetics and Food Service, Institut Kanser Negara
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Institute
City
Putrajaya
ZIP/Postal Code
62250
Country
Malaysia

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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