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

General Surgery Clinical Trial

— PNAS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03115931
• Other study ID #: 201502022-1
• Status: Completed
• Start date: April 14, 2017
• Est. completion date: April 26, 2019

Study information

• Verified date: May 2019
• Source: Jinling Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4880
• Est. completion date: April 26, 2019
• Est. primary completion date: February 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Clinical Outcomes
• General Surgery
• Nutrition Assessment
• Nutritional Support

Intervention

Other:
• no intervention
no intervention

Locations

Country	Name	City	State
China	Jinling Hospital, China	Nanjing	Jiangsu

Sponsors (13)

Lead Sponsor

Collaborator

Jinling Hospital, China

Changhai Hospital, Chinese PLA General Hospital, 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 First Affiliated Hospital of Kunming Medical College, The Second Affiliated Hospital of Harbin Medical University, West China Hospital, Xijing Hospital, Xinqiao Hospital of Chongqing

Country where clinical trial is conducted

China, 

References & Publications (6)

American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) Board of Directors. Clinical Guidelines for the Use of Parenteral and Enteral Nutrition in Adult and Pediatric Patients, 2009. JPEN J Parenter Enteral Nutr. 2009 May-Jun;33(3):255-9. doi: 10.1177/0148607109333115. — View Citation

Braga M, Ljungqvist O, Soeters P, Fearon K, Weimann A, Bozzetti F; ESPEN. ESPEN Guidelines on Parenteral Nutrition: surgery. Clin Nutr. 2009 Aug;28(4):378-86. doi: 10.1016/j.clnu.2009.04.002. Epub 2009 May 21. — View Citation

Doig GS, Simpson F, Sweetman EA, Finfer SR, Cooper DJ, Heighes PT, Davies AR, O'Leary M, Solano T, Peake S; Early PN Investigators of the ANZICS Clinical Trials Group. Early parenteral nutrition in critically ill patients with short-term relative contraindications to early enteral nutrition: a randomized controlled trial. JAMA. 2013 May 22;309(20):2130-8. doi: 10.1001/jama.2013.5124. — View Citation

Studley HO. Percentage of weight loss: a basic indicator of surgical risk in patients with chronic peptic ulcer. 1936. Nutr Hosp. 2001 Jul-Aug;16(4):141-3; discussion 140-1. — View Citation

Weimann A, Braga M, Harsanyi L, Laviano A, Ljungqvist O, Soeters P; DGEM (German Society for Nutritional Medicine), Jauch KW, Kemen M, Hiesmayr JM, Horbach T, Kuse ER, Vestweber KH; ESPEN (European Society for Parenteral and Enteral Nutrition). ESPEN Guidelines on Enteral Nutrition: Surgery including organ transplantation. Clin Nutr. 2006 Apr;25(2):224-44. Epub 2006 May 15. — View Citation

Wilmore DW, Dudrick SJ. Growth and development of an infant receiving all nutrients exclusively by vein. JAMA. 1968 Mar 4;203(10):860-4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morbidity of infection	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	Nutrition indicator	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.
Secondary	Length of stay in hospital	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.
Secondary	Actual calories intake	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.
Secondary	Mortality	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.