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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03115931
Recruitment Status : Completed
First Posted : April 14, 2017
Last Update Posted : May 14, 2019
Sponsor:
Collaborators:
Peking Union Medical College Hospital
Chinese PLA General Hospital
First Affiliated Hospital, Sun Yat-Sen University
Xijing Hospital
West China Hospital
Xinqiao Hospital of Chongqing
Second Affiliated Hospital, School of Medicine, Zhejiang University
Changhai Hospital
Shanghai 10th People's Hospital
The Second Affiliated Hospital of Harbin Medical University
The Affiliated Hospital of Qingdao University
The First Affiliated Hospital of Kunming Medical College
Information provided by (Responsible Party):
Wang Xinying, Jinling Hospital, China

Brief Summary:
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.

Condition or disease Intervention/treatment
Nutrition Assessment Nutritional Support Clinical Outcomes General Surgery Other: no intervention

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.

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Study Type : Observational
Actual Enrollment : 4880 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Preoperative Nutritional Assessment and Nutritional Support on Clinical Outcomes in Elective Abdominal Surgery Patients: A Prospective Observational Study
Actual Study Start Date : April 14, 2017
Actual Primary Completion Date : February 27, 2019
Actual Study Completion Date : April 26, 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: no intervention
    no intervention


Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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

  4. 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.


Biospecimen Retention:   Samples Without DNA
The serum were collected to assess the nutrition risk.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients undergoing selective operation without trauma.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03115931


Locations
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China, Jiangsu
Jinling Hospital, China
Nanjing, Jiangsu, China, 210000
Sponsors and Collaborators
Jinling Hospital, China
Peking Union Medical College Hospital
Chinese PLA General Hospital
First Affiliated Hospital, Sun Yat-Sen University
Xijing Hospital
West China Hospital
Xinqiao Hospital of Chongqing
Second Affiliated Hospital, School of Medicine, Zhejiang University
Changhai Hospital
Shanghai 10th People's Hospital
The Second Affiliated Hospital of Harbin Medical University
The Affiliated Hospital of Qingdao University
The First Affiliated Hospital of Kunming Medical College
Investigators
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Principal Investigator: Xinying Wang, PhD Jinling Hospital, China
Publications:

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Responsible Party: Wang Xinying, Professor, Chief of Clinical Nutrition Service, Jinling Hospital, China
ClinicalTrials.gov Identifier: NCT03115931    
Other Study ID Numbers: 201502022-1
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No