Colorectal DisordersNCT02940665
A Comparison of Protein Intake Between ERAS and Conventional Care After Elective Colorectal Surgery
An observational study of Colorectal Disorders and Surgery, run by University of Calgary.
Trial summary
The primary objective of this prospective cohort study is to compare protein intake and adequacy between patients receiving Enhanced Recovery After Surgery (ERAS) protocols with patients receiving conventional care. The study will also compare energy intakes, gut function, and clinical outcomes between groups. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colorectal Disorders, Surgery
- What is being tested?
- ERAS
- How many people
- 115 participants
- Where
- No sites listed yet
- Study dates
- Mar 2014to May 2016
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Colorectal surgery
Who may be able to join
- adult patients ≥18 years of age
- elective colorectal resection
Who cannot join
- co-morbidities that could have interfered with oral intake (e.g., dysphagia)
- concurrent enteral or parenteral nutrition prior to surgery were excluded since food intakes could be influenced by these conditions.
About this study
Official title: Higher Protein Intakes Are Associated With Reduced Length of Stay: A Comparison Between ERAS and Conventional Care After Elective Colorectal Surgery
The primary objective of this prospective cohort study is to compare protein intake and adequacy between patients receiving Enhanced Recovery After Surgery (ERAS) protocols with patients receiving conventional care. The study will also compare energy intakes, gut function, and clinical outcomes between groups. The ability of nutritional parameters, including preoperative malnutrition risk and postoperative protein intake, to predict length of hospital stay will be evaluated.
- Conditions
- Colorectal Disorders, Surgery
- Being tested
- ERAS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERASOther
Patients in the ERAS group received the ERAS protocol
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Recovery After Surgery (ERAS) | ERAS group followed the ERAS protocol. The protocol was implemented 13 months prior to the start of data collection. Receives: Other: ERAS | |
| Conventional | Conventional group received conventional care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total protein intake (grams) as assessed by food records.
Protein intake from food records on postoperative days 1, 2 and 3 will be recorded. Patients will record the amount of food, fluid, and oral nutrition supplements consumed using quartiles (none, ¼, ½, ¾, all) on a food record. Research staff will verify the self-reported food records with the patients after each meal. Total protein intake in grams will be determined by comparing actual food intake (obtained from the food records) to the food composition records of our institution.
Measured: Average in first three postoperative days
Secondary outcomes (1)
Length of hospital stay (number of days)
Total length of hospital stay will be recorded in days beginning at admission for surgery until discharge.
Measured: Number of days spent in hospital during admission for surgery up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2016 (estimated)
- Study startMar 2014
- Primary completionApr 2015
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal DisordersStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Foundation for Dietetic Research (CFDR)
- Responsible party
- Principal investigator, Dr. Tanis Fenton, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02940665
- Sponsor's protocol ID
- 13-1337
- Status last verified
- May 2017
- First submitted
- 14 Oct 2016
- Last updated
- 3 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Yeung SE, Hilkewich L, Gillis C, Heine JA, Fenton TR. Protein intakes are associated with reduced length of stay: a comparison between Enhanced Recovery After Surgery (ERAS) and conventional care after elective colorectal surgery. Am J Clin Nutr. 2017 Jul;106(1):44-51. doi: 10.3945/ajcn.116.148619. Epub 2017 May 3.
PubMed 28468890
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Higher Protein Intakes Are Associated With Reduced Length of Stay: A Comparison Between ERAS and Conventional Care After Elective Colorectal Surgery
- ClinicalTrials.gov ID
- NCT02940665
- Acronym / sponsor ID
- 13-1337
- Conditions
- Colorectal Disorders, Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Canadian Foundation for Dietetic Research (CFDR)
- Study start
- Mar 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 21 Oct 2016 (estimated)
- 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 prospective cohort study is to compare protein intake and adequacy between patients receiving Enhanced Recovery After Surgery (ERAS) protocols with patients receiving conventional care. The study will also compare energy intakes, gut function, and clinical outcomes between groups. The ability of nutritional parameters, including preoperative malnutrition risk and postoperative protein intake, to predict length of hospital stay will be evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced Recovery After Surgery (ERAS) | – | Other: ERASERAS group followed the ERAS protocol. The protocol was implemented 13 months prior to the start of data collection. |
| Conventional | – | –Conventional group received conventional care. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Colorectal surgery
Key inclusion criteria (2 listed)
- adult patients ≥18 years of age
- elective colorectal resection
Key exclusion criteria (2 listed)
- co-morbidities that could have interfered with oral intake (e.g., dysphagia)
- concurrent enteral or parenteral nutrition prior to surgery were excluded since food intakes could be influenced by these conditions.
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 |
|---|---|---|
| ERASPatients in the ERAS group received the ERAS protocol | Other | Enhanced Recovery After Surgery (ERAS) |
Primary outcome
Total protein intake (grams) as assessed by food records.
Time frame: Average in first three postoperative days
Protein intake from food records on postoperative days 1, 2 and 3 will be recorded. Patients will record the amount of food, fluid, and oral nutrition supplements consumed using quartiles (none, ¼, ½, ¾, all) on a food record. Research staff will verify the self-reported food records with the patients after each meal. Total protein intake in grams will be determined by comparing actual food intake (obtained from the food records) to the food composition records of our institution.
1 secondary outcome
Length of hospital stay (number of days)
Time frame: Number of days spent in hospital during admission for surgery up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2017.
- Derived from this study: PubMed 28468890Yeung SE, Hilkewich L, Gillis C, Heine JA, Fenton TR. Protein intakes are associated with reduced length of stay: a comparison between Enhanced Recovery After Surgery (ERAS) and conventional care after elective colorectal surgery. Am J Clin Nutr. 2017 Jul;106(1):44-51. doi: 10.3945/ajcn.116.148619. Epub 2017 May 3.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Disorders and Surgery, run by University of Calgary.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 3 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total protein intake (grams) as assessed by food records. (time frame: Average in first three postoperative days). 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 NCT02940665, which also lists 1 linked publication.
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 3 May 2017.