Ileostomy; ComplicationsNCT04675606
Implementing a Low Fiber Diet vs. Regular Diet in Postoperative Colorectal Patients With Ileostomies
A study testing Regular diet and Low fiber diet in people with Ileostomy; Complications and Bowel Obstruction, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Ileostomy; Complications, Bowel Obstruction, Postoperative Ileus
- What is being tested?
- Regular diet and Low fiber diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Oct 2020to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Cedars Sinai Medical Center
Los Angeles, California, 90048
Lucille Yao, MD, 310-289-9224, lucille.yao@cshs.org
Karen Zaghiyan, MD, 310-289-9224, karen.zaghiyan@cshs.org
About this study
Official title: A Prospective Randomized Trial of Low Fiber Diet vs. Regular Diet in Postoperative Colorectal Patients With Ileostomies
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.
Read the 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.
- Being tested
- Regular diet, Low fiber diet
- Keywords
- Ileostomy, Bowel obstruction, Postoperative ileus, Low fiber diet, Regular diet
- Medical subject headings
- Intestinal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regular dietBehavioural
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 dietBehavioural
Also called Low residue 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
| Study group | Role | What they receive |
|---|---|---|
| Low fiber diet | Active comparator | Patients in this arm will receive low fiber diet starting postoperative day 1. This is currently the standard protocol at our institution. Receives: Behavioral: Low fiber diet |
| Regular diet | Experimental | Patients in this arm will receive regular diet starting postoperative day 1. This will be the experimental arm. Receives: Behavioral: Regular diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days postoperatively
Secondary outcomes (7)
Hospital readmission rates
Hospital readmission rates
Measured: 90 days postoperatively
Hospital length of stay
Hospital length of stay
Measured: Up to 90 days postoperatively
Volume of stoma output
Average daily volume of stoma output
Measured: 90 days postoperatively
Need for antidiarrheal use
Need for antidiarrheal use
Measured: 90 days postoperatively
Average maximum daily nausea score
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.
Measured: 90 days postoperatively
Average maximum daily pain score
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.
Measured: 90 days postoperatively
Quality of life
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.
Measured: 90 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start21 Oct 2020
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Ileostomy; ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen Zaghiyan, Cedars-Sinai Medical Center
- Investigators
- Karen Zaghiyan, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04675606
- Sponsor's protocol ID
- STUDY00000894
- Status last verified
- Oct 2022
- First submitted
- 2 Dec 2020
- Last updated
- 24 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23703645Chapman 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.
PubMed 29469195Correia 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.
PubMed 15295279Eypasch 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.
PubMed 7749697Feo 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.
PubMed 15144242Levenstein 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.
PubMed 2996991Ljungqvist 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.
PubMed 28097305Ray 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.
PubMed 31326707Reissman 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.
PubMed 7618972Wood 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.
PubMed 28916971
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Trial of Low Fiber Diet vs. Regular Diet in Postoperative Colorectal Patients With Ileostomies
- ClinicalTrials.gov ID
- NCT04675606
- Acronym / sponsor ID
- STUDY00000894
- Keywords
- Ileostomy, Bowel obstruction, Postoperative ileus, Low fiber diet, Regular diet
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 21 Oct 2020 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 19 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low fiber diet | Active comparator | Behavioral: Low fiber dietPatients in this arm will receive low fiber diet starting postoperative day 1. This is currently the standard protocol at our institution. |
| Regular diet | Experimental | Behavioral: Regular dietPatients in this arm will receive regular diet starting postoperative day 1. This will be the experimental arm. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regular dietPatients 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). | Behavioural | Regular diet |
| Low fiber dietAlso: Low residue dietPatients 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 | Behavioural | Low fiber diet |
Primary outcome
Rate of postoperative ileus and obstruction
Time frame: 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.
7 secondary outcomes
Hospital readmission rates
Time frame: 90 days postoperatively
Hospital length of stay
Time frame: Up to 90 days postoperatively
Volume of stoma output
Time frame: 90 days postoperatively
Need for antidiarrheal use
Time frame: 90 days postoperatively
Average maximum daily nausea score
Time frame: 90 days postoperatively
Average maximum daily pain score
Time frame: 90 days postoperatively
Quality of life
Time frame: 90 days postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2022.
- Background: PubMed 23703645Austin 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.
- Background: PubMed 29469195Chapman 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.
- Background: PubMed 15295279Correia 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.
- Background: PubMed 7749697Eypasch 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.
- Background: PubMed 15144242Feo 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.
- Background: PubMed 2996991Levenstein 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.
- Background: PubMed 28097305Ljungqvist 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.
- Background: PubMed 31326707Ray 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.
- Background: PubMed 7618972Reissman 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.
- Background: PubMed 28916971Wood 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Zaghiyan, MD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regular diet and Low fiber diet in people with Ileostomy; Complications and Bowel Obstruction, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lucille Yao, MD (310-289-9224, lucille.yao@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of postoperative ileus and obstruction (time frame: 90 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04675606, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2022.