Early Nutrition Impact on Post Abdominal Surgery Outcome

September 28, 2020 updated by: Mostafa Farouk, Cairo University

Impact of Early Enteral & Parenteral Nutrition on Post-operative Outcome After Abdominal Surgery

Introduction: Nutritional support is a vital therapy of most surgical patients. Early initiation via the enteral route has a significant effect on postoperative recovery. The prognostic role of CRP and albumin can be explained by their abilities to reflect inflammation in the acute phase in critical settings and assess the nutritional status of critically ill patients, respectively. This indicates the prognostic value of the CRP/ALB ratio in postoperative patients admitted to the ICU.

Aim of work: Determine the effect of early enteral & parenteral nutrition on ICU outcome & nutritional status in postoperative abdominal surgical patients and investigate the effect of enteral & parenteral nutrition on CRP/albumin ratio as an inflammatory marker & its correlation with SOFA score.

Methods: A prospective cohort non randomized study included 80 postoperative abdominal surgical patients at Critical Care Department, Cairo University over one year duration. Forty patients (50%) received enteral nutrition 6 hours after surgical procedures and 40 patients (50%) received parenteral nutrition 6 hours after surgical procedures. Nutritional status and inflammatory markers were screened. All patients were followed up during the ICU stay & up to 3 months. SOFA scoring was done every 48 hours.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study included patients with age more than 18 years underwent major abdominal surgeries.

Pre-operative nutrition screening was done using Nutritional risk screening (NRS 2000).

Patients were divided into two groups: Group A: 40 patients (50%) received enteral nutrition 6 hours after surgical procedure & Group B: 40 patients (50%) received parenteral nutrition 6 hours after surgical procedure according to the surgeons preference.

Enteral feeding in group (A) was started 6 hours postoperatively via ryle tube or feeding jejunostomy including proteins (1.5 gm/kg/day) with a caloric value (4.1 kcal/gm), fat (caloric value = 9 kcal/gm) & carbohydrates.

Parenteral feeding in group (B) was started 6 hours postoperatively using SmofKabiven Peripheral [FRESENIUS KABI] : 1200 ml , 38 gm amino acids, 34 gm lipids, 85 gm glucose, osmolarity 850 mosmol/L with total energy approximately 800Kcal.

Description

Inclusion Criteria:

  • postoperative abdominal surgical patients at Critical Care Department, Cairo University over one year duration.
  • age between 18-80 years

Exclusion Criteria:

  • renal failure
  • liver failure
  • extensive burns
  • hemodynamic instability.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Enteral Nutrition
Dietary supplement: postoperative nutrition
Forty patients (50%) received enteral nutrition 6 hours after surgical procedures and 40 patients (50%) received parenteral nutrition 6 hours after surgical procedures.
Parenteral nutrition
Dietary supplement: postoperative nutrition
Forty patients (50%) received enteral nutrition 6 hours after surgical procedures and 40 patients (50%) received parenteral nutrition 6 hours after surgical procedures.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Gastro-intestinal tolerance: vomitting or diarrhea
Time Frame: 7 days
number of participants who develop nausea, vomitting or diarrhea
7 days
Refeeding syndrome; hypokalemia and hypophosphatemia
Time Frame: 7 days
number of participants who develop hypokalemia and hypophosphatemia
7 days
length of ICU stay
Time Frame: 7 days
measurement of days of ICU stay
7 days
duration of mechanical ventilation.
Time Frame: 7 days
measurement of days of mechanical ventilation
7 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
3 months survival after discharge .
Time Frame: 90 days
measurement of the rate of survival within 3 months between participants
90 days
re-admission within 30 days
Time Frame: 30 days
measurement of the rate of hospital re-admission within 30 days between participants
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 20, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 28, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 30, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 28, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MS-311-2016

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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