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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02940665
• Other study ID #: 13-1337
• Status: Completed
• Phase: N/A
• First received: October 14, 2016
• Last updated: May 1, 2017
• Start date: March 2014
• Est. completion date: May 2016

Study information

• Verified date: May 2017
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: May 2016
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Disorders
• Surgery

Intervention

Other:
• ERAS
Patients in the ERAS group received the ERAS protocol

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Calgary	Canadian Foundation for Dietetic Research (CFDR)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Length of hospital stay (number of days)	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