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NCT Number: NCT03115931

The Effect of Preoperative Nutritional Assessment and Nutritional Support on Clinical Outcomes

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.

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Key information

Conditions

Nutrition Assessment Clinical Outcomes General Surgery Nutritional Support

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Jinling Hospital, China

Nanjing, Jiangsu, 210000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

No intervention

Other

no intervention

Primary outcomes

  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 outcomes

  1. Resting Energy Expenditure (REE) by Indirect Calorimetry

    Time frame: From date of patients enrollment until the date of patients discharge from hospital, assessed up to 2 months.

    REE was measured by indirect calorimetry (Q-NRG®) on postoperative days 1, 3, and 5 under standardized fasting and resting conditions.

  2. 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

  3. 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.

  4. 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

  5. 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.

Sponsors and collaborators

Lead sponsor

Jinling Hospital, China

Other

Collaborators

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

Registry information

Official study title

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

Acronym: PNAS

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 14, 2017
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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