Implementing a Low Fiber Diet vs. Regular Diet in Postoperative Colorectal Patients With Ileostomies
A Prospective Randomized Trial of Low Fiber Diet vs. Regular Diet in Postoperative Colorectal Patients With Ileostomies
1 other identifier
interventional
160
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 21, 2020
CompletedFirst Submitted
Initial submission to the registry
December 2, 2020
CompletedFirst Posted
Study publicly available on registry
December 19, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedOctober 24, 2022
October 1, 2022
3.2 years
December 2, 2020
October 20, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of postoperative ileus and obstruction
evaluate rate of post-operative ileus or obstruction in patients with ileostomies receiving low fiber diet vs. regular diet starting post-operative day 1.
90 days postoperatively
Secondary Outcomes (7)
Hospital readmission rates
90 days postoperatively
Hospital length of stay
Up to 90 days postoperatively
Volume of stoma output
90 days postoperatively
Need for antidiarrheal use
90 days postoperatively
Average maximum daily nausea score
90 days postoperatively
- +2 more secondary outcomes
Study Arms (2)
Low fiber diet
ACTIVE COMPARATORPatients in this arm will receive low fiber diet starting postoperative day 1. This is currently the standard protocol at our institution.
Regular diet
EXPERIMENTALPatients in this arm will receive regular diet starting postoperative day 1. This will be the experimental arm.
Interventions
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).
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
Related Publications (10)
Austin SR, Wong YN, Uzzo RG, Beck JR, Egleston BL. Why Summary Comorbidity Measures Such As the Charlson Comorbidity Index and Elixhauser Score Work. Med Care. 2015 Sep;53(9):e65-72. doi: 10.1097/MLR.0b013e318297429c.
PMID: 23703645BACKGROUNDChapman SJ, Pericleous A, Downey C, Jayne DG. Postoperative ileus following major colorectal surgery. Br J Surg. 2018 Jun;105(7):797-810. doi: 10.1002/bjs.10781. Epub 2018 Feb 22.
PMID: 29469195BACKGROUNDCorreia MI, da Silva RG. The impact of early nutrition on metabolic response and postoperative ileus. Curr Opin Clin Nutr Metab Care. 2004 Sep;7(5):577-83. doi: 10.1097/00075197-200409000-00011.
PMID: 15295279BACKGROUNDEypasch E, Williams JI, Wood-Dauphinee S, Ure BM, Schmulling C, Neugebauer E, Troidl H. Gastrointestinal Quality of Life Index: development, validation and application of a new instrument. Br J Surg. 1995 Feb;82(2):216-22. doi: 10.1002/bjs.1800820229.
PMID: 7749697BACKGROUNDFeo CV, Romanini B, Sortini D, Ragazzi R, Zamboni P, Pansini GC, Liboni A. Early oral feeding after colorectal resection: a randomized controlled study. ANZ J Surg. 2004 May;74(5):298-301. doi: 10.1111/j.1445-1433.2004.02985.x.
PMID: 15144242BACKGROUNDLevenstein S, Prantera C, Luzi C, D'Ubaldi A. Low residue or normal diet in Crohn's disease: a prospective controlled study in Italian patients. Gut. 1985 Oct;26(10):989-93. doi: 10.1136/gut.26.10.989.
PMID: 2996991BACKGROUNDLjungqvist O, Scott M, Fearon KC. Enhanced Recovery After Surgery: A Review. JAMA Surg. 2017 Mar 1;152(3):292-298. doi: 10.1001/jamasurg.2016.4952.
PMID: 28097305BACKGROUNDRay S, Mehta NN, Mangla V, Lalwani S, Mehrotra S, Chugh P, Yadav A, Nundy S. A Comparison Between the Comprehensive Complication Index and the Clavien-Dindo Grading as a Measure of Postoperative Outcome in Patients Undergoing Gastrointestinal Surgery-A Prospective Study. J Surg Res. 2019 Dec;244:417-424. doi: 10.1016/j.jss.2019.06.093. Epub 2019 Jul 18.
PMID: 31326707BACKGROUNDReissman P, Teoh TA, Cohen SM, Weiss EG, Nogueras JJ, Wexner SD. Is early oral feeding safe after elective colorectal surgery? A prospective randomized trial. Ann Surg. 1995 Jul;222(1):73-7. doi: 10.1097/00000658-199507000-00012.
PMID: 7618972BACKGROUNDWood T, Aarts MA, Okrainec A, Pearsall E, Victor JC, McKenzie M, Rotstein O, McLeod RS; iERAS group. Emergency Room Visits and Readmissions Following Implementation of an Enhanced Recovery After Surgery (iERAS) Program. J Gastrointest Surg. 2018 Feb;22(2):259-266. doi: 10.1007/s11605-017-3555-2. Epub 2017 Sep 15.
PMID: 28916971BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karen Zaghiyan, MD
Cedars-Sinai Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Surgery
Study Record Dates
First Submitted
December 2, 2020
First Posted
December 19, 2020
Study Start
October 21, 2020
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
October 24, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share