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

Phase

N/A

Condition

Colic

Bowel Dysfunction

Constipation

Treatment

N/A

Clinical Study ID

NCT04675606

STUDY00000894

Ages 18-90
All Genders
Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

Refusal to participate in the study
Undergoing emergent colorectal surgery. Emergent colorectal surgery is defined aspatients who require immediate surgery < 24hrs after initial decision for surgery ismade
Patients expected to require intensive care unit (ICU) admission postoperatively
Age <18 or > 90 years
Pregnancy
Patient with preoperative short-bowel syndrome or proximal stomas (jejunostomy)
Patients on preoperative total parenteral nutrition not expected to immediatelycommence postoperative enteral nutrition
Patients maintained NPO for any reason after surgery

Study Design

October 21, 2020

December 31, 2023

Study Description

The proposed study is a prospective randomized study to compare two post-operative diets

Low fiber diet
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.

Connect with a study center

Cedars Sinai Medical Center
Los Angeles, California 90048
United States
Active - Recruiting

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