A Comparison of Protein Intake Between ERAS and Conventional Care After Elective Colorectal Surgery

May 1, 2017 updated by: Dr. Tanis Fenton, University of Calgary

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

115

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Colorectal surgery

Description

Inclusion Criteria:

  • adult patients ≥18 years of age
  • elective colorectal resection

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Enhanced Recovery After Surgery (ERAS)
ERAS group followed the ERAS protocol. The protocol was implemented 13 months prior to the start of data collection.
Other: ERAS
Patients in the ERAS group received the ERAS protocol
Conventional
Conventional group received conventional care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Average in first three postoperative days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of hospital stay (number of days)
Time Frame: Number of days spent in hospital during admission for surgery up to 6 months
Total length of hospital stay will be recorded in days beginning at admission for surgery until discharge.
Number of days spent in hospital during admission for surgery up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Calgary

Collaborators

Canadian Foundation for Dietetic Research (CFDR)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

October 14, 2016

First Submitted That Met QC Criteria

October 19, 2016

First Posted (Estimate)

October 21, 2016

Study Record Updates

Last Update Posted (Actual)

May 3, 2017

Last Update Submitted That Met QC Criteria

May 1, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 13-1337

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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