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

Sponsor

University of Calgary (Other)

Overall Status

Completed

CT.gov ID

NCT02940665

Collaborator

Canadian Foundation for Dietetic Research (CFDR) (Other)

115

Enrollment

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Disorders Surgery	Other: ERAS

Study Design

Study Type:

Observational

Actual Enrollment :

115 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Higher Protein Intakes Are Associated With Reduced Length of Stay: A Comparison Between ERAS and Conventional Care After Elective Colorectal Surgery

Study Start Date :

Mar 1, 2014

Actual Primary Completion Date :

Apr 1, 2015

Actual Study Completion Date :

May 1, 2016

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Total protein intake (grams) as assessed by food records. [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.

Secondary Outcome Measures

Length of hospital stay (number of days) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Calgary
Canadian Foundation for Dietetic Research (CFDR)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr. Tanis Fenton, Associate Professor, University of Calgary

ClinicalTrials.gov Identifier:

NCT02940665

Other Study ID Numbers:

13-1337

First Posted:

Oct 21, 2016

Last Update Posted:

May 3, 2017

Last Verified:

May 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Study Results

No Results Posted as of May 3, 2017