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

NCT03115931 | Completed DMC

• 1 other identifier: 201502022-1
• Study Type: observational
• Target: 4,880
• Locations: 1 country
• Sites: 1

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.

Conditions

Nutrition Assessment; Nutritional Support; Clinical Outcomes; General Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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.

• Nutrition indicator

  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.

• 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.

Interventions

no intervention OTHER

no intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing selective operation without trauma.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Jinling Hospital, China

Nanjing, Jiangsu, 210000, China

Location

Related Publications (6)

• 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. doi: 10.1016/j.clnu.2006.01.015. Epub 2006 May 15.

  PMID: 16698152 BACKGROUND

• 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. No abstract available.

  PMID: 11680474 BACKGROUND

• Wilmore DW, Dudrick SJ. Growth and development of an infant receiving all nutrients exclusively by vein. JAMA. 1968 Mar 4;203(10):860-4. No abstract available.

  PMID: 4965871 BACKGROUND

• 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.

  PMID: 19464088 BACKGROUND

• 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. No abstract available.

  PMID: 19398611 BACKGROUND

• 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.

  PMID: 23689848 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

The serum were collected to assess the nutrition risk.

Study Officials

• Xinying Wang, PhD

  Jinling Hospital, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Chief of Clinical Nutrition Service

Study Record Dates

• First Submitted: March 29, 2017
• First Posted: April 14, 2017
• Study Start: April 14, 2017
• Primary Completion: February 27, 2019
• Study Completion: April 26, 2019
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)