Nutritional and Functional Assessment of Patients Undergoing Surgery Due to Gastrointestinal Cancer (NUFAGI).

Gastrointestinal Cancer Clinical Trial

— NUFAGI  

Official title:

Nutritional and Functional Assessment of Patients Undergoing Surgery Due to Gastrointestinal Cancer (NUFAGI): a Prospective Cohort Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05795374
• Other study ID #: NUFAGI 2022
• Status: Completed
• Start date: March 1, 2022
• Est. completion date: December 20, 2023

Study information

• Verified date: December 2023
• Source: National and Kapodistrian University of Athens
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Several patients that suffer from gastrointestinal (GI) cancer are characterized by malnutrition and impairment of their functional status. The aim of the present study is to evaluate the nutritional condition of patients undergoing surgery due to GI cancer and compare it with their functional status. All consecutive patients with esophageal, gastric, colorectal, hepatocellular, pancreatic and biliary cancer, that underwent a surgical operation will be included. Demographic characteristics, nutritional assessment and anthropometric measurements of the patients will be recorded.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 20, 2023
• Est. primary completion date: December 20, 2023
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Patients undergoing a surgical operation due to esophageal, gastric, colorectal, hepatocellular, pancreatic and biliary cancer.

Exclusion Criteria:

• Under 18 years old or above 99 years old.

• Surgery due to benign conditions.

Related Conditions & MeSH terms

• Gastrointestinal Cancer
• Gastrointestinal Neoplasms

Locations

Country	Name	City	State
Greece	Hippocration General Hospital	Athens

Sponsors (1)

Lead Sponsor	Collaborator
Maximos Frountzas

Country where clinical trial is conducted

Greece, 

References & Publications (5)

Gomes de Lima KV, Maio R. Nutritional status, systemic inflammation and prognosis of patients with gastrointestinal cancer. Nutr Hosp. 2012 May-Jun;27(3):707-14. doi: 10.3305/nh/2012.27.3.5567. — View Citation

Huhmann MB, Cunningham RS. Importance of nutritional screening in treatment of cancer-related weight loss. Lancet Oncol. 2005 May;6(5):334-43. doi: 10.1016/S1470-2045(05)70170-4. — View Citation

Leandro-Merhi VA, de Aquino JL. Determinants of malnutrition and post-operative complications in hospitalized surgical patients. J Health Popul Nutr. 2014 Sep;32(3):400-10. — View Citation

Pathirana AK, Lokunarangoda N, Ranathunga I, Santharaj WS, Ekanayake R, Jayawardena R. Prevalence of hospital malnutrition among cardiac patients: results from six nutrition screening tools. Springerplus. 2014 Aug 7;3:412. doi: 10.1186/2193-1801-3-412. eCollection 2014. — View Citation

Pirlich M, Schutz T, Norman K, Gastell S, Lubke HJ, Bischoff SC, Bolder U, Frieling T, Guldenzoph H, Hahn K, Jauch KW, Schindler K, Stein J, Volkert D, Weimann A, Werner H, Wolf C, Zurcher G, Bauer P, Lochs H. The German hospital malnutrition study. Clin Nutr. 2006 Aug;25(4):563-72. doi: 10.1016/j.clnu.2006.03.005. Epub 2006 May 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative morbidity.	Complications after surgery.	30 days
Secondary	Mortality.	Number of deaths.	30 days
Secondary	Disease stage	TNM after histological examination	1 month
Secondary	Recurrence	Disease recurrence	1 year