NCT04675606

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

A Prospective Randomized Trial of Low Fiber Diet vs. Regular Diet in Postoperative Colorectal Patients With Ileostomies

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Cedars-Sinai Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

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.

Detailed description

The proposed study is a prospective randomized study to compare two post-operative diets 1. Low fiber diet 2. Regular diet in patients undergoing elective or urgent colorectal surgery resulting in a loop or end ileostomy. The primary outcome measure is rate of post-operative ileus or obstruction in patients with ileostomies. The secondary objectives of this study are to compare the length of stay, 30-day and 90-day readmission rates, rate of high stoma output requiring antidiarrheal medication, nausea score, pain score, and overall quality of life amongst the patients studied. All groups will be counseled and asked to consent for the study at the time of their preoperative clinic visit and copy of the protocol will be provided to them. Patients undergoing urgent surgery will be counseled and consented at the time decision for surgery is made. All groups will be started on either low fiber diet or regular diet on postoperative day 1. Of note, it is important to note that at our institution, a "low fiber diet" is equivalent to a "low residue diet" in our electronic medical records system. All groups will be assessed and examined daily, where nausea score and pain score will be recorded. Prior to discharge, both groups will receive consultation with a wound-ostomy care nurse who will perform ostomy teaching as well as diet/nutritional counseling. Patients in the low fiber diet arm will receive nutritional counseling advising that they follow a low fiber diet. Patients in the regular diet arm will receive nutritional counseling advising that they continue to follow a regular diet.

Conditions

• Ileostomy; Complications
• Bowel Obstruction
• Postoperative Ileus

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-10-21
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2020-12-19
• Last updated: 2022-10-24

Locations

1 site across 1 country: United States