Clinical trial NCT03115931: The Effect of Preoperative Nutritional Assessment and Nutritional Support on Clinical Outcomes
Official title: The Effect of Preoperative Nutritional Assessment and Nutritional Support on Clinical Outcomes in Elective Abdominal Surgery Patients: A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nutrition Assessment
Nutritional Support
Clinical Outcomes
General Surgery
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
Collaborators: name: Peking Union Medical College Hospital
name: Chinese PLA General Hospital
name: First Affiliated Hospital, Sun Yat-Sen University
name: Xijing Hospital
name: West China Hospital
name: Xinqiao Hospital of Chongqing
name: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Changhai Hospital
name: Shanghai 10th People's Hospital
name: The Second Affiliated Hospital of Harbin Medical University
name: The Affiliated Hospital of Qingdao University
name: First Affiliated Hospital of Kunming Medical University
First posted: 2017-04-14
Enrollment: 4880
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing selective operation without trauma.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Morbidity of infection
timeFrame: From date of patients enrollment until the date of infection documented from any cause, assessed up to 2 months.
Secondary outcomes:
measure: Nutrition indicator
timeFrame: From date of patients enrollment until the date of patients discharge from hospital, assessed up to 2 months.
measure: Length of stay in hospital
timeFrame: From date of patients enrollment until the date of patients discharged from hospital, assessed up to 12 months.
measure: Actual calories intake
timeFrame: From date of patients enrollment until the date of patients are subjected to operation, assessed up to 2 months.
measure: Mortality
timeFrame: From date of patients enrollment until the date of death from any cause, assessed up to 2 months after patients discharged from hospital.
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jinling Hospital, China
state: Jiangsu
Study officials:
affiliation: Jinling Hospital, China
name: Xinying Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1016/j.clnu.2006.01.015. Epub 2006 May 15.
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. No abstract available.
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. No abstract available.
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.
citation: 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.
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.