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

Not Applicable

Recruiting

• Conditions: Ileostomy; Complications; Bowel Obstruction; Postoperative Ileus
• Interventions: Behavioral: Low fiber diet; Behavioral: Regular diet

• Registration Number: NCT04675606
• Lead Sponsor: Cedars-Sinai Medical Center

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.

Study Timeline

• Study Start: 2020-10-21
• Study First Submitted: 2020-12-02
• Study First Submitted QC: 2020-12-15
• Study First Posted: 2020-12-19
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-20
• Last Update Posted: 2022-10-24
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low fiber diet	Low fiber diet	Patients in this arm will receive low fiber diet starting postoperative day 1. This is currently the standard protocol at our institution.
Regular diet	Regular diet	Patients in this arm will receive regular diet starting postoperative day 1. This will be the experimental arm.

Primary Outcome Measures

Name	Time	Method
Rate of postoperative ileus and obstruction	90 days postoperatively	evaluate rate of post-operative ileus or obstruction in patients with ileostomies receiving low fiber diet vs. regular diet starting post-operative day 1.

Secondary Outcome Measures

Name	Time	Method
Hospital readmission rates	90 days postoperatively	Hospital readmission rates
Average maximum daily nausea score	90 days postoperatively	Average maximum daily nausea score on a scale of 0 to 2. A score of 0 means no presence of nausea, 1 denotes presence of nausea, and 2 denotes presence of vomiting. A higher score up to a maximum of 2 means a worse outcome compared to a lower score.
Average maximum daily pain score	90 days postoperatively	Average maximum daily pain score on a scale of 0 to 10. A score of 0 means a patient has no pain. A higher score up to the maximum of 10 means a worse outcome.
Hospital length of stay	Up to 90 days postoperatively	Hospital length of stay
Volume of stoma output	90 days postoperatively	Average daily volume of stoma output
Need for antidiarrheal use	90 days postoperatively	Need for antidiarrheal use
Quality of life	90 days postoperatively	Quality of life assessed using the Gastrointestinal Quality of Life Index (GIQLI) questionnaire. The GIQLI questionnaire has 36 items, each item is scored 0 to 4. The GIQLI has a range of 0 to 144. Higher score up to a maximum of 144 means better outcome.

Trial Locations

Locations (1)

Cedars Sinai Medical Center; 🇺🇸 Los Angeles, California, United States