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

Sponsor

Cedars-Sinai Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT04675606

Collaborator

(none)

160

Enrollment

Location

Arms

24.3

Anticipated Duration (Months)

6.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ileostomy; Complications Bowel Obstruction Postoperative Ileus	Behavioral: Regular diet Behavioral: Low fiber diet	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

160 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Dec 21, 2020

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	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 Other Names: Low residue diet
Experimental: Regular diet Patients in this arm will receive regular diet starting postoperative day 1. This will be the experimental arm.	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).

Arm

Intervention/Treatment

Active Comparator: 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.

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

Other Names:

Low residue diet

Experimental: Regular diet

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

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).

Outcome Measures

Primary Outcome Measures

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

Hospital readmission rates [90 days postoperatively]
Hospital readmission rates
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
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Male or Female
Undergoing elective or urgent major laparoscopic or open colorectal procedure resulting in new loop or end ileostomy creation
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.
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 Criteria:

Refusal to participate in the study
Undergoing emergent colorectal surgery. Emergent colorectal surgery is defined as patients who require immediate surgery < 24hrs after initial decision for surgery is made
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 immediately commence postoperative enteral nutrition
Patients maintained NPO for any reason after surgery