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

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

• Registration Number: NCT03357848
• Lead Sponsor: Federal University of Minas Gerais

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-19
• Status Verified: 2017-11
• Study First Submitted: 2017-11-22
• Study First Submitted QC: 2017-11-29
• Last Update Submitted: 2017-11-29
• Study First Posted: 2017-11-30
• Last Update Posted: 2017-11-30
• Primary Completion: 2018-03
• Study Completion: 2018-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postoperative complications	30 days after surgery	According to the Dindo-Clavien protocol

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital of Clinics of the University Federal of Minas Gerais; 🇧🇷 Belo Horizonte, Minas Gerais, Brazil