Clinical trial NCT04675606: Implementing a Low Fiber Diet vs. Regular Diet in Postoperative Colorectal Patients With Ileostomies
Official title: A Prospective Randomized Trial of Low Fiber Diet vs. Regular Diet in Postoperative Colorectal Patients With Ileostomies
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ileostomy; Complications
Bowel Obstruction
Postoperative Ileus
Keywords: Ileostomy
Bowel obstruction
Postoperative ileus
Low fiber diet
Regular diet
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2020-12-19
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of postoperative ileus and obstruction
timeFrame: 90 days postoperatively
Secondary outcomes:
measure: Hospital readmission rates
timeFrame: 90 days postoperatively
measure: Hospital length of stay
timeFrame: Up to 90 days postoperatively
measure: Volume of stoma output
timeFrame: 90 days postoperatively
measure: Need for antidiarrheal use
timeFrame: 90 days postoperatively
measure: Average maximum daily nausea score
timeFrame: 90 days postoperatively
measure: Average maximum daily pain score
timeFrame: 90 days postoperatively
measure: Quality of life
timeFrame: 90 days postoperatively
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Karen Zaghiyan, MD
role: PRINCIPAL_INVESTIGATOR
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