SurgeryNCT03357848
Impact of Caloric and Protein Adequacy on Postoperative Clinical Outcomes of Patients Undergoing Major Abdominal Surgery
An observational study of Surgery and Postoperative Complications, run by Federal University of Minas Gerais at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery, Postoperative Complications, Cancer
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 19 Dec 2016to Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing major abdominal surgery at the University Hospital of University Federal of Minas Gerais
Who may be able to join
- Over 18 years old
- Patients admitted for major abdominal surgery
- Sign the consent form
Who cannot join
- Length of hospital stay less than 3 days
- Pregnancy
- Patients who, for any reason, can not perform indirect calorimetry
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital of Clinics of the University Federal of Minas Gerais
Belo Horizonte, Minas Gerais
Isabel Correia, isabel_correia@uol.com.br
About this study
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.
- Medical subject headings
- Postoperative Complications, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complications
According to the Dindo-Clavien protocol
Measured: 30 days after surgery
Secondary outcomes (5)
Phase angle
Changes in phase angle after surgery as measured by bioelectrical impedance
Measured: 24 hours pre-surgery, 3 and 7 days after surgery
Body composition
Changes in body composition after surgery as measured by bioelectrical impedance
Measured: 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)
Measured: 24 hours pre-surgery and 7 days after surgery
Functional status
Changes in functional status after surgery as assessed by hand grip strength
Measured: 24 hours pre-surgery, 3 and 7 days after surgery
Energy expenditure
Changes in energy expenditure after surgery measured by indirect calorimetry
Measured: 3, 5 and 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2017
- Study start19 Dec 2016
- Primary completionMar 2018 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do estado de Minas Gerais, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Maria Isabel Toulson Davisson Correia, Federal University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03357848
- Sponsor's protocol ID
- CAAE-12279713.1.0000.5149
- Status last verified
- Nov 2017
- First submitted
- 22 Nov 2017
- Last updated
- 30 Nov 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Caloric and Protein Adequacy on Postoperative Clinical Outcomes of Patients Undergoing Major Abdominal Surgery
- ClinicalTrials.gov ID
- NCT03357848
- Acronym / sponsor ID
- CAAE-12279713.1.0000.5149
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do estado de Minas Gerais, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- 19 Dec 2016 (actual)
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 30 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing major abdominal surgery at the University Hospital of University Federal of Minas Gerais
Key inclusion criteria (3 listed)
- Over 18 years old
- Patients admitted for major abdominal surgery
- Sign the consent form
Key exclusion criteria (3 listed)
- Length of hospital stay less than 3 days
- Pregnancy
- Patients who, for any reason, can not perform indirect calorimetry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postoperative complications
Time frame: 30 days after surgery
According to the Dindo-Clavien protocol
5 secondary outcomes
Phase angle
Time frame: 24 hours pre-surgery, 3 and 7 days after surgery
Body composition
Time frame: 24 hours pre-surgery, 3 and 7 days after surgery
Nutritional status
Time frame: 24 hours pre-surgery and 7 days after surgery
Functional status
Time frame: 24 hours pre-surgery, 3 and 7 days after surgery
Energy expenditure
Time frame: 3, 5 and 7 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery and Postoperative Complications, run by Federal University of Minas Gerais at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Isabel TD Correia, PHD (+55 31 991688239, isabel_correia@uol.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative complications (time frame: 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2017.