Clinical trial NCT05795374: Nutritional and Functional Assessment of Patients Undergoing Surgery Due to Gastrointestinal Cancer (NUFAGI).
Official title: Nutritional and Functional Assessment of Patients Undergoing Surgery Due to Gastrointestinal Cancer (NUFAGI): a Prospective Cohort Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastrointestinal Cancer
Keywords: nutritional status
functional status
gastrointestinal cancer
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
First posted: 2023-04-03
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients with esophageal, gastric, colorectal, hepatocellular, pancreatic and biliary cancer, that underwent a surgical operation.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Postoperative morbidity.
timeFrame: 30 days
Secondary outcomes:
measure: Mortality.
timeFrame: 30 days
measure: Disease stage
timeFrame: 1 month
measure: Recurrence
timeFrame: 1 year
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Hippocration General Hospital
Study officials:
affiliation: National and Kapodistrian University of Athens
name: Konstantinos G Toutouzas, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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.
citation: 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.
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.