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

Cedars-Sinai Medical Center

Status: Enrolling

Conditions: Postoperative Ileus; Ileostomy; Complications; Bowel Obstruction

Treatments: Behavioral: Regular diet; Behavioral: Low fiber diet

Study type: Interventional

Funder types: Other

Identifiers

NCT04675606

STUDY00000894

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Male or Female
2. Undergoing elective or urgent major laparoscopic or open colorectal procedure resulting in new loop or end ileostomy creation
3. Urgent colorectal surgery is defined as operations performed during the same hospital admission, but greater than 24hrs after decision for surgery is made. Patients undergoing urgent colorectal surgery are not expected to require intensive care unit (ICU) admission postoperatively.
4. Willingness and ability to sign an informed consent document
5. No allergies to anesthetic or antiemetic
6. ASA physical status Class I - III
7. Aged 18-90 years

Exclusion criteria

1. Refusal to participate in the study
2. Undergoing emergent colorectal surgery. Emergent colorectal surgery is defined as patients who require immediate surgery < 24hrs after initial decision for surgery is made
3. Patients expected to require intensive care unit (ICU) admission postoperatively
4. Age <18 or > 90 years
5. Pregnancy
6. Patient with preoperative short-bowel syndrome or proximal stomas (jejunostomy)
7. Patients on preoperative total parenteral nutrition not expected to immediately commence postoperative enteral nutrition
8. Patients maintained NPO for any reason after surgery

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Low fiber diet

Active Comparator group

Description:

Patients in this arm will receive low fiber diet starting postoperative day 1. This is currently the standard protocol at our institution.

Treatment:

Behavioral: Low fiber diet

Regular diet

Experimental group

Description:

Patients in this arm will receive regular diet starting postoperative day 1. This will be the experimental arm.

Treatment:

Behavioral: Regular diet