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

NCT03357848 | Unknown

• 1 other identifier: CAAE-12279713.1.0000.5149
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery; Postoperative Complications; Cancer; Energy Supply; Deficiency

Outcome Measures

Primary Outcomes (1)

• Postoperative complications

  According to the Dindo-Clavien protocol

  30 days after surgery

Secondary Outcomes (5)

• Phase angle

  24 hours pre-surgery, 3 and 7 days after surgery

• Body composition

  24 hours pre-surgery, 3 and 7 days after surgery

• Nutritional status

  24 hours pre-surgery and 7 days after surgery

• Functional status

  24 hours pre-surgery, 3 and 7 days after surgery

• Energy expenditure

  3, 5 and 7 days after surgery

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Hospital of Clinics of the University Federal of Minas Gerais

Belo Horizonte, Minas Gerais, Brazil

RECRUITING

MeSH Terms

Conditions

Postoperative Complications; Neoplasms

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Maria Isabel TD Correia, PHD

CONTACT

+55 31 991688239; isabel_correia@uol.com.br

Thales Antonio Silva

CONTACT

+55 31 982850073; antoniothales37@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor/ Nutrition Service Coordinator

Study Record Dates

• First Submitted: November 22, 2017
• First Posted: November 30, 2017
• Study Start: December 19, 2016
• Primary Completion: March 1, 2018
• Study Completion: August 1, 2018
• Last Updated: November 30, 2017

Record last verified: 2017-11

Locations

BR (1)