Impact of Caloric and Protein Adequacy on Postoperative Clinical Outcomes of Patients Undergoing Major Abdominal Surgery

The role of nutritional therapy (TN) in the surgical patient is well described in the literature and is associated with reductions in postoperative complications, length of hospital stay, and mortality. Adequate determination of caloric and protein requirements is an essential step in the TN institution, avoiding hypoalimentation and hyperalimentation. Thus, it is essential to understand the changes in energy expenditure after surgery and its relation with nutritional status. In addition, little is known about the effect of nutritional therapy and caloric adequacy on parameters such as phase angle and dynamometry. Thus, the objective of this study is to evaluate the changes in energy expenditure after major abdominal surgeries and to evaluate the phase angle and dynamometry as possible markers of nutritional therapy. Energy expenditure will be assessed by indirect calorimetry. Functionality will be assessed by means of dynamometry and 6-minute walk test. Nutritional diagnosis will be given through subjective global assessment. Energy and protein intake will be monitored and registered daily. Phase angle will be obtained by performing bioelectrical impedance.

Study Overview

• Status: Unknown
• Conditions: Postoperative Complications; Cancer; Surgery; Energy Supply; Deficiency

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• Brazil
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil
      • Recruiting
      • Hospital of Clinics of the University Federal of Minas Gerais
      • Contact: Isabel Correia; Email: isabel_correia@uol.com.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing major abdominal surgery at the University Hospital of University Federal of Minas Gerais

Description

Inclusion Criteria:

• Over 18 years old
• Patients admitted for major abdominal surgery
• Sign the consent form

Exclusion Criteria:

• Length of hospital stay less than 3 days
• Pregnancy
• Patients who, for any reason, can not perform indirect calorimetry

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Study group; Surgical patients receiving nutritional support (enteral and/or parenteral nutrition) pre and/or after surgery
Control group; Surgical patients without nutritional support during the perioperative period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative complications	According to the Dindo-Clavien protocol	30 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase angle	Changes in phase angle after surgery as measured by bioelectrical impedance	24 hours pre-surgery, 3 and 7 days after surgery
Body composition	Changes in body composition after surgery as measured by bioelectrical impedance	24 hours pre-surgery, 3 and 7 days after surgery
Nutritional status	Changes in nutritional status after surgery as assessed by subjective global assessment (SGA)	24 hours pre-surgery and 7 days after surgery
Functional status	Changes in functional status after surgery as assessed by hand grip strength	24 hours pre-surgery, 3 and 7 days after surgery
Energy expenditure	Changes in energy expenditure after surgery measured by indirect calorimetry	3, 5 and 7 days after surgery

Collaborators and Investigators

• Sponsor: Federal University of Minas Gerais
• Collaborators: Conselho Nacional de Desenvolvimento Científico e Tecnológico; Fundação de Amparo à Pesquisa do estado de Minas Gerais

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2016
• Primary Completion (Anticipated): March 1, 2018
• Study Completion (Anticipated): August 1, 2018

Study Registration Dates

• First Submitted: November 22, 2017
• First Submitted That Met QC Criteria: November 29, 2017
• First Posted (Actual): November 30, 2017

Study Record Updates

• Last Update Posted (Actual): November 30, 2017
• Last Update Submitted That Met QC Criteria: November 29, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: CAAE-12279713.1.0000.5149

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No