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Completed

NCT Number: NCT04678349

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Cancer Institute

Putrajaya, 62250, Malaysia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Conventional care

Other

follow low fibre diet and anti-diarrhea drugs

Primary outcomes

  1. ileostomy stoma output

    Time frame: up to 1 month

    consistency (bristrol stool chart; range 1-7; 1 hard while 7 watery)

  2. ileostomy stoma output

    Time frame: up to 1 month

    volume (ml)

Secondary outcomes

  1. Length of hospital stay

    Time frame: up to 1 month

    days of hospital stays

  2. Readmission within 30-days discharged

    Time frame: up to 1 month

    readmit to ward due to complications after discharge

  3. Dietary intake

    Time frame: up to 1 month

    energy (kcal/day)

  4. dietary intake

    Time frame: up to 1 month

    protein intake (g/day)

Sponsors and collaborators

Lead sponsor

Universiti Putra Malaysia

Other

Collaborators

  • National Cancer Institute, Malaysia

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 21, 2020
Registry last updated
Nov 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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