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

Completed

• Conditions: Clinical Outcomes; General Surgery; Nutrition Assessment; Nutritional Support

• Registration Number: NCT03115931
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2017-03-29
• Study First Submitted QC: 2017-04-13
• Study Start: 2017-04-14
• Study First Posted: 2017-04-14
• Primary Completion: 2019-02-27
• Study Completion: 2019-04-26
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-13
• Last Update Posted: 2019-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4880

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Morbidity of infection	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

Name	Time	Method
Length of stay in hospital	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.
Actual calories intake	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
Mortality	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.
Nutrition indicator	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

Trial Locations

Locations (1)

Jinling Hospital, China; 🇨🇳 Nanjing, Jiangsu, China