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

NCT04678349 | Completed DMC

• 1 other identifier: NMRR-19-3119-51323
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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

Study Arms (2)

PHGG

EXPERIMENTAL

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

CG

OTHER

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

Interventions

PHGG DIETARY_SUPPLEMENT

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.

PHGG

conventional care OTHER

follow low fibre diet and anti-diarrhea drugs

CG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cancer patients with ileostomy
• At least 18 years of age
• Malaysian

You may not qualify if:

• Not cancer patients with ileostomy
• Patients who participate in other study at the same time
• Vulnerable subjects
• Palliative patients
• Patient has fistula

Sponsors & Collaborators

• Universiti Putra Malaysia: lead
• National Cancer Institute, Malaysia: collaborator

Study Sites (1)

National Cancer Institute

Putrajaya, 62250, Malaysia

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• ChiouYi Ho

  Department of Dietetics and Food Service, Institut Kanser Negara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 24, 2020
• First Posted: December 21, 2020
• Study Start: May 1, 2021
• Primary Completion: September 28, 2021
• Study Completion: November 29, 2021
• Last Updated: November 4, 2022

Record last verified: 2022-11

Locations

MY (1)