The Effect of Preoperative Nutritional Assessment and Nutritional Support on Clinical Outcomes (PNAS)

May 13, 2019 updated by: Wang Xinying, Jinling Hospital, China

The Effect of Preoperative Nutritional Assessment and Nutritional Support on Clinical Outcomes in Elective Abdominal Surgery Patients: A Prospective Observational Study

It is a study to evaluate the relationship between preoperative nutritional assessment and clinical outcomes and to explore the effect of preoperative nutritional support on clinical outcomes in patients after abdominal operation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

It is a multi-center prospective observational cohort study to evaluate the relationship between preoperative nutritional assessment and clinical outcomes and to explore the effect of preoperative nutritional support on clinical outcomes in patients after abdominal operation. The nutrition risk were evaluated by different methods. The nutrition support regimens and the clinical outcomes were recorded.

Study Type

Observational

Enrollment (Actual)

4880

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Jinling Hospital, China

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

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients undergoing selective operation without trauma.

Description

Inclusion Criteria:

  1. Informed consent of patients or their legal representatives to participate in this study.
  2. patients undergoing selective operation without trauma

Exclusion Criteria:

  1. Age: <18 years old or >80 years old
  2. Discharge within 24 hours
  3. Accept surgery at 8:00 next day
  4. Withdraw of patient's informed consent

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morbidity of infection
Time Frame: From date of patients enrollment until the date of infection documented from any cause, assessed up to 2 months.
Invasion of the host organism by microorganisms that can cause pathological conditions or diseases.
From date of patients enrollment until the date of infection documented from any cause, assessed up to 2 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nutrition indicator
Time Frame: From date of patients enrollment until the date of patients discharge from hospital, assessed up to 2 months.
albumin/prealbumin/transferrin/retinol binding protein/IL-6
From date of patients enrollment until the date of patients discharge from hospital, assessed up to 2 months.
Length of stay in hospital
Time Frame: From date of patients enrollment until the date of patients discharged from hospital, assessed up to 12 months.
The length of patients stay in hospital.
From date of patients enrollment until the date of patients discharged from hospital, assessed up to 12 months.
Actual calories intake
Time Frame: From date of patients enrollment until the date of patients are subjected to operation, assessed up to 2 months.
The total energy patients received during the study
From date of patients enrollment until the date of patients are subjected to operation, assessed up to 2 months.
Mortality
Time Frame: From date of patients enrollment until the date of death from any cause, assessed up to 2 months after patients discharged from hospital.
All deaths reported in all enrolled patients.
From date of patients enrollment until the date of death from any cause, assessed up to 2 months after patients discharged from hospital.

Collaborators and Investigators

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

Sponsor

Jinling Hospital, China

Collaborators

Xijing Hospital
Changhai Hospital
Peking Union Medical College Hospital
Chinese PLA General Hospital
First Affiliated Hospital, Sun Yat-Sen University
West China Hospital
Second Affiliated Hospital, School of Medicine, Zhejiang University
The Affiliated Hospital of Qingdao University
Shanghai 10th People's Hospital
Xinqiao Hospital of Chongqing
The First Affiliated Hospital of Kunming Medical College
The Second Affiliated Hospital of Harbin Medical University

Investigators

  • Principal Investigator: Xinying Wang, PhD, Jinling Hospital, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

April 14, 2017

Primary Completion (Actual)

February 27, 2019

Study Completion (Actual)

April 26, 2019

Study Registration Dates

First Submitted

March 29, 2017

First Submitted That Met QC Criteria

April 13, 2017

First Posted (Actual)

April 14, 2017

Study Record Updates

Last Update Posted (Actual)

May 14, 2019

Last Update Submitted That Met QC Criteria

May 13, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 201502022-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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