Status:
UNKNOWN
Implementing a Low Fiber Diet vs. Regular Diet in Postoperative Colorectal Patients With Ileostomies
Lead Sponsor:
Cedars-Sinai Medical Center
Conditions:
Ileostomy; Complications
Bowel Obstruction
Eligibility:
All Genders
18-90 years
Phase:
NA
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-operat...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT04675606
Start Date
October 21 2020
End Date
December 31 2023
Last Update
October 24 2022
Active Locations (1)
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1
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048