NCT02940665

Brief 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. The ability of nutritional parameters, including preoperative malnutrition risk and postoperative protein intake, to predict length of hospital stay will be evaluated.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2014

Typical duration for all trials

Status
completed

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

March 1, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 14, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 21, 2016

Completed
Last Updated

May 3, 2017

Status Verified

May 1, 2017

Enrollment Period

1.1 years

First QC Date

October 14, 2016

Last Update Submit

May 1, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Average in first three postoperative days

Secondary Outcomes (1)

  • Length of hospital stay (number of days)

    Number of days spent in hospital during admission for surgery up to 6 months

Study Arms (2)

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

Conventional

Conventional group received conventional care.

Interventions

ERASOTHER

Patients in the ERAS group received the ERAS protocol

Enhanced Recovery After Surgery (ERAS)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Colorectal surgery

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 14, 2016

First Posted

October 21, 2016

Study Start

March 1, 2014

Primary Completion

April 1, 2015

Study Completion

May 1, 2016

Last Updated

May 3, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share