Recruiting

Low Fiber Diet vs. Regular Diet

Sponsor:

Cedars-Sinai Medical Center

Code:

NCT04675606

Conditions

Ileostomy; Complications

Bowel Obstruction

Postoperative Ileus

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Regular diet

Low fiber diet

Study Details

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.

Conditions

Ileostomy; Complications

Bowel Obstruction

Postoperative Ileus

Study ID

NCT04675606

Start date

Oct 21, 2020

Status verified date

Oct, 2022

Completion date

Dec 31, 2023

Anticipated

Primary completion date

Dec 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

experimental: Regular diet

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

Interventions

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).

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

Primary outcome measure

  • Rate of postoperative ileus and obstruction [ Time Frame: 90 days postoperatively ]

Central Contacts and Locations

Central contacts

Lucille Yao, MD

310-289-9224lucille.yao@cshs.org

Karen Zaghiyan, MD

310-289-9224karen.zaghiyan@cshs.org

Locations

Cedars Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Lucille Yao, MD

310-289-9224lucille.yao@cshs.org

Karen Zaghiyan, MD

310-289-9224karen.zaghiyan@cshs.org

Principal Investigator:

Karen Zaghiyan, MD

More Information

Sponsor

Cedars-Sinai Medical Center

Last update posted

Oct 24, 2022

Last verified

Oct, 2022

Keywords

  • Ileostomy
  • Bowel obstruction
  • Postoperative ileus
  • Low fiber diet
  • Regular diet

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Cedars-Sinai Medical Center on 2022-10-24.