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Implementing a Low Fiber Diet vs. Regular Diet in Postoperative Colorectal Patients With Ileostomies

NCT04675606 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2022-10-24

No results posted yet for this study

Summary

The primary objective of this study is to prospectively evaluate rate of post-operative ileus or obstruction in patients with ileostomies receiving low fiber diet vs. regular diet starting post-operative day 1. The secondary objectives of this study are to compare the 30-day and 90-day readmission rates, length of stay, rate of high stoma output or need for antidiarrheals within 90 days, nausea score, level of pain, and overall quality of life amongst the patients studied.

Conditions

  • Ileostomy; Complications
  • Bowel Obstruction
  • Postoperative Ileus

Interventions

BEHAVIORAL

Regular diet

Patients in the regular diet arm (which is the experimental arm) will not have any diet limitations and will be recommended to consume a healthy balanced diet for American adults as recommended by the United States Department of Agriculture (USDA) and US Food and Drug Administration (FDA).

BEHAVIORAL

Low fiber diet

Patients in the low fiber diet arm (which is the control arm) will be recommended to consume foods that are low in fiber content per United Ostomy Associations of America Recommendations

Sponsors & Collaborators

  • Cedars-Sinai Medical Center

    lead OTHER

Principal Investigators

  • Karen Zaghiyan, MD · Cedars-Sinai Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-21
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04675606 on ClinicalTrials.gov