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

NCT ID: NCT03357848

Last Updated: 2017-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-19

Study Completion Date

2018-08-31

Brief Summary

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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

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Conditions

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Surgery Postoperative Complications Cancer Energy Supply; Deficiency

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Study group

Surgical patients receiving nutritional support (enteral and/or parenteral nutrition) pre and/or after surgery

No interventions assigned to this group

Control group

Surgical patients without nutritional support during the perioperative period

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundação de Amparo à Pesquisa do estado de Minas Gerais

OTHER

Sponsor Role collaborator

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role collaborator

Federal University of Minas Gerais

OTHER

Sponsor Role lead

Responsible Party

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Maria Isabel Toulson Davisson Correia

Professor/ Nutrition Service Coordinator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital of Clinics of the University Federal of Minas Gerais

Belo Horizonte, Minas Gerais, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Maria Isabel TD Correia, PHD

Role: CONTACT

Phone: +55 31 991688239

Email: [email protected]

Thales Antonio Silva

Role: CONTACT

Phone: +55 31 982850073

Email: [email protected]

Facility Contacts

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Isabel Correia

Role: primary

Other Identifiers

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CAAE-12279713.1.0000.5149

Identifier Type: -

Identifier Source: org_study_id