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Clinical Trials/NCT03115931
NCT03115931CompletedNot Applicable

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

Jinling Hospital, China1 site in 1 country4,880 target enrollmentStarted: November 14, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
4,880
Locations
1
Primary Endpoint
Morbidity of infection

Study Overview

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.

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

  • Resting Energy Expenditure (REE) by Indirect Calorimetry(From date of patients enrollment until the date of patients discharge from hospital, assessed up to 2 months.)
  • Length of stay in hospital(From date of patients enrollment until the date of patients discharged from hospital, assessed up to 12 months.)
  • Nutrition indicator(From date of patients enrollment until the date of patients discharge from hospital, assessed up to 2 months.)
  • Actual calories intake(From date of patients enrollment until the date of patients are subjected to operation, assessed up to 2 months.)
  • Mortality(From date of patients enrollment until the date of death from any cause, assessed up to 2 months after patients discharged from hospital.)

Investigators

Sponsor
Jinling Hospital, China
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Wang Xinying

Professor, Chief of Clinical Nutrition Service

Jinling Hospital, China

Study Sites (1)

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